Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA |
Webinar |
2/24/2022 |
Drug Development, Generic Drug Development |
OTC Monograph Reform: Deemed Final Orders |
Webinar |
12/15/2021 |
OTC Drug Regulation |
OTC Monograph Reform: OTC Sunscreen Drugs |
Webinar |
12/15/2021 |
OTC Drug Regulation |
Clinical Investigator Training Course (CITC) Update |
Webinar |
12/7/2021 |
Clinical Trials and Research, New Drug Development |
Pharmaceutical Quality Symposium 2021: Innovations in a Changing World |
Conference/Workshop |
10/26/2021 |
Drug Quality |
Pharmaceutical Quality Symposium 2021 Part 1 with Keynote Addresses |
Conference/Workshop |
10/26/2021 |
Drug Quality |
Pharmaceutical Quality Symposium 2021 Part 2, FDA Leaders Panel Discussion |
Conference/Workshop |
10/26/2021 |
Drug Quality |
Pharmaceutical Quality Symposium 2021 Part 3 Panel Questions and Discussion |
Conference/Workshop |
10/26/2021 |
Drug Quality |
Pharmaceutical Quality Symposium 2021 Part 4 |
Conference/Workshop |
10/26/2021 |
Drug Quality |
Pharmaceutical Quality Symposium 2021 Part 5 |
Conference/Workshop |
10/26/2021 |
Drug Quality |
Pharmaceutical Quality Symposium 2021 Part 6 |
Conference/Workshop |
10/26/2021 |
Drug Quality |
Pharmaceutical Quality Symposium 2021 Part 7 |
Conference/Workshop |
10/26/2021 |
Drug Quality |
Pharmaceutical Quality Symposium 2021 Part 8 |
Conference/Workshop |
10/26/2021 |
Drug Quality |
Electronic Drug Registration and Listing (eDRLS) Using CDER Direct Part 1 with Keynote Address |
Conference/Workshop |
10/13/2021 |
Registration and Listing |
Electronic Drug Registration and Listing (eDRLS) Using CDER Direct Part 2 |
Conference/Workshop |
10/13/2021 |
Registration and Listing |
Electronic Drug Registration and Listing (eDRLS) Using CDER Direct Part 3 |
Conference/Workshop |
10/13/2021 |
Registration and Listing |
Electronic Drug Registration and Listing (eDRLS) Using CDER Direct Part 4 with Closing Remarks |
Conference/Workshop |
10/13/2021 |
Registration and Listing |
Electronic Drug Registration and Listing (eDRLS) Using CDER Direct |
Conference/Workshop |
10/13/2021 |
Registration and Listing |
|
Webinar |
10/5/2021 |
DSCSA |
Investigator Responsibilities — Safety Reporting for Investigational Drugs and Device |
Webinar |
9/29/2021 |
IND, Safety |
Advancing Generic Drug Development: Translating Science to Approval |
Conference/Workshop |
9/21/2021 |
Generic Drug Development |
Advancing Generic Drug Development: Translating Science to Approval Keynote Address |
Conference/Workshop |
9/15/2021 |
Generic Drug Development |
COVID-19 Impact on Generic Drug Regulation and Evaluation + QA |
Conference/Workshop |
9/15/2021 |
Generic Drug Development |
Considerations in Assessing Generic Drug Products of Oral Dosage Forms + QA |
Conference/Workshop |
9/15/2021 |
Generic Drug Development |
Complex Generics_Complex Injectables, Opthalmic, and Otic Products, Part 1 + QA |
Conference/Workshop |
9/15/2021 |
Generic Drug Development |
Complex Generics_Complex Injectables, Opthalmic, and Otic Products, Part 2 + QA |
Conference/Workshop |
9/15/2021 |
Generic Drug Development |
Advancing Generic Drug Development: Translating Science to Approval, Day One Closing Remarks |
Conference/Workshop |
9/15/2021 |
Generic Drug Development |
Cutting Edge Science in Complex Generics + QA |
Conference/Workshop |
9/15/2021 |
Generic Drug Development |
Complex Generics_Nasal and Inhalation Products + QA |
Conference/Workshop |
9/15/2021 |
Generic Drug Development |
Complex Generics_Topical Products, Part 1 + QA |
Conference/Workshop |
9/15/2021 |
Generic Drug Development |
Complex Generics_Topical Products, Part 2 + QA |
Conference/Workshop |
9/15/2021 |
Generic Drug Development |
Advancing Generic Drug Development: Translating Science to Approval, Day Two Closing Remarks |
Conference/Workshop |
9/15/2021 |
Generic Drug Development |
The ABCs of Product Specific Guidances |
CDER SBIA Chronicles |
9/2/2021 |
Generic Drug Development |
The ABCs of Product Specific Guidances |
CDER SBIA Chronicles Podcast |
9/2/2021 |
Generic Drug Development |
Promotional Submissions in eCTD Format – Grouped Submissions |
Webinar |
8/31/2021 |
Regulatory Submissions |
Manufacturing, Supply Chain, and Inspections during the COVID19 Public Health Emergency |
Webinar |
8/25/2021 |
Inspections; Drug Quality; DSCSA |
Regulatory Education for Industry (REdI) Annual Conference 2021 |
Conference/Workshop |
7/19/2021 |
New Drug Development |
2021 REdI Conference Keynote Address by Janet Woodcock, MD |
Conference/Workshop |
7/19/2021 |
New Drug Development |
2021 REdI Conference Plenary Session with Patrizia Cavazzoni, MD |
Conference/Workshop |
7/19/2021 |
New Drug Development |
OND Reorganization and the New Drugs Regulatory Program Modernization |
Conference/Workshop |
7/19/2021 |
New Drug Development |
ANDA Efforts Related to COVID-19 |
Conference/Workshop |
7/19/2021 |
Generic Drug Development |
Resource Capacity Planning: How CDER is Modernizing Resource Planning Capabilities |
Conference/Workshop |
7/19/2021 |
New Drug Development |
CDER NextGen Portal |
Conference/Workshop |
7/19/2021 |
Regulatory Submissions |
Electronic Common Technical Document (eCTD) |
Conference/Workshop |
7/19/2021 |
Regulatory Submissions |
Product Quality Consideration for Emergency Use Authorizations (EUAs) |
Conference/Workshop |
7/19/2021 |
New Drug Development |
Strategies to Address Potential Medication Errors for EUA Products for COVID-19 |
Conference/Workshop |
7/19/2021 |
New Drug Development; Safety |
Clinical Pharmacology Regulatory Sciences in Drug Development and Precision Medicine |
Conference/Workshop |
7/19/2021 |
New Drug Development |
CDER’s Role in Public Health Emergency Response and Medical Countermeasure Development |
Conference/Workshop |
7/19/2021 |
New Drug Development |
Where Do We Go from Here? How the Ombudsman Can Help |
Conference/Workshop |
7/19/2021 |
FDA Meetings/Communications |
Communication Best Practices – Interacting with Regulatory Project Managers in CDER/ORO |
Conference/Workshop |
7/19/2021 |
FDA Meetings/Communications |
Communications in a Global Pandemic |
Conference/Workshop |
7/19/2021 |
FDA Meetings/Communications |
Regulatory Policy: Role in Guiding Decision Making in CDER |
Conference/Workshop |
7/19/2021 |
New Drug Development |
Role of the Product Jurisdiction Team in the Medical Product Development Process |
Conference/Workshop |
7/19/2021 |
New Drug Development |
FDA Guidance on Conduct of Clinical Trials of Medical Products During the Public Health Emergency |
Conference/Workshop |
7/19/2021 |
New Drug Development; Clinical Trials and Research |
OSI’s Role in the Drug Development Process and Impact of COVID-19 |
Conference/Workshop |
7/19/2021 |
New Drug Development |
Identification of Medicinal Products: Path to Global Implementation |
Webinar |
6/11/2021 |
International, Labeling, Regulatory Submissions |
|
Webinar |
6/3/2021 |
OTC Drug Regulation |
FDA Study Data Technical Rejection Criteria (TRC): What you need to know! |
Webinar |
5/21/2021 |
Regulatory Submissions |
FY 2021 Generic Drug Science and Research Initiatives Public Workshop |
Conference/Workshop |
6/23/2021 |
Generic Drug Development |
Welcome, Keynote, and Industry Survey Results - GDUFA Science and Research Initiatives Public Workshop |
Conference/Workshop |
6/23/2021 |
Generic Drug Development |
Generic Industry Challenge Perspectives - GDUFA Science and Research Initiatives Public Workshop |
Conference/Workshop |
6/23/2021 |
Generic Drug Development |
Public Comment - GDUFA Science and Research Initiatives Public Workshop |
Conference/Workshop |
6/23/2021 |
Generic Drug Development |
Panel Discussion with Generic Industry - GDUFA Science and Research Initiatives Public Workshop |
Conference/Workshop |
6/23/2021 |
Generic Drug Development |
Model-Integrated Evidence for Generic Drug Development – Session 1A |
Conference/Workshop |
6/23/2021 |
Generic Drug Development |
Model-Integrated Evidence for Generic Drug Development – Session 1B |
Conference/Workshop |
6/23/2021 |
Generic Drug Development |
Model-Integrated Evidence for Generic Drug Development – Session 1C |
Conference/Workshop |
6/23/2021 |
Generic Drug Development |
Complex Product Characterization/Analysis - Session 2A |
Conference/Workshop |
6/23/2021 |
Generic Drug Development |
Complex Product Characterization/Analysis - Session 2B |
Conference/Workshop |
6/23/2021 |
Generic Drug Development |
Complex Product Characterization/Analysis - Session 2C |
Conference/Workshop |
6/23/2021 |
Generic Drug Development |
In Vitro and In Vivo BE Approaches: Challenges and Opportunities – Session 3A |
Conference/Workshop |
6/23/2021 |
Generic Drug Development |
In Vitro and In Vivo BE Approaches: Challenges and Opportunities – Session 3B |
Conference/Workshop |
6/23/2021 |
Generic Drug Development |
Closing Remarks - Robert Lioberger, PhD, Director, Office of Research and Standards (ORS), OGD, FDA |
Conference/Workshop |
6/23/2021 |
Generic Drug Development |
FDA and Health Canada Regional ICH Consultation |
Conference/Workshop |
5/14/2021 |
Clinical Trials and Research; International; New Drug Development |
FDA and Health Canada Regional ICH Consultation - Part I |
Conference/Workshop |
5/14/2021 |
Clinical Trials and Research; International; New Drug Development |
FDA and Health Canada Regional ICH Consultation - Part II |
Conference/Workshop |
5/14/2021 |
Clinical Trials and Research; International; New Drug Development |
Common Labeling Deficiencies and Tips for Generic Drug Applications |
Webinar |
5/7/2021 |
Generic Drug Development; Labeling |
FDA Product-Specific Guidances: Lighting the Development Pathway for Generic Drugs |
Webinar |
5/5/2021 |
Generic Drug Development; New Drug Development; Orange Book |
Generic Drugs Forum 2021: Lifecycle of a Generic Drug |
Conference/Workshop |
4/28/2021 |
Generic Drug Development |
Generic Drugs Forum 2021: Lifecycle of a Generic Drug: Keynote from Sally Choe, Director, Office of Generic Drugs (OGD) |
Conference/Workshop |
4/28/2021 |
Generic Drug Development |
Office of Pharmaceutical Quality (OPQ) Update |
Conference/Workshop |
4/28/2021 |
Generic Drug Development; Drug Quality |
Global Generic Drug Landscape |
Conference/Workshop |
4/28/2021 |
Generic Drug Development |
Data Integrity Issues in Bioequivalence Studies |
Conference/Workshop |
4/28/2021 |
Generic Drug Development; Drug Quality |
Bioavailability/Bioequivalence Site Evaluation During the Pandemic |
Conference/Workshop |
4/28/2021 |
Generic Drug Development |
Impact of Data Integrity Issues on Pharmacology/Toxicology Studies in ANDAs |
Conference/Workshop |
4/28/2021 |
Generic Drug Development; Drug Quality |
Generic Drugs Forum 2021: Panel Discussion 1 |
Conference/Workshop |
4/28/2021 |
Generic Drug Development |
OPQ Policy Update |
Conference/Workshop |
4/28/2021 |
Generic Drug Development; Drug Quality |
Update on CDER’s Quality Management Maturity Program |
Conference/Workshop |
4/28/2021 |
Generic Drug Development |
Generic Drugs Forum 2021: Panel Discussion 2 |
Conference/Workshop |
4/28/2021 |
Generic Drug Development |
Pre-ANDA Program |
Conference/Workshop |
4/28/2021 |
Generic Drug Development; FDA Meetings/Communications |
Pre-ANDA Program Update and Tips for Success – OPQ Perspective |
Conference/Workshop |
4/28/2021 |
Generic Drug Development; Drug Quality |
Controlled Correspondence Related to Pharmaceutical Quality |
Conference/Workshop |
4/28/2021 |
Generic Drug Development; FDA Meetings/Communications |
Generic Drugs Forum 2021: Panel Discussion 3 |
Conference/Workshop |
4/28/2021 |
Generic Drug Development |
Division of Filing Review: Helpful Tips for Submission of an ANDA or Controlled Correspondence |
Conference/Workshop |
4/28/2021 |
Generic Drug Development |
>ANDA Labeling: Recommendations and Helpful Resources |
Conference/Workshop |
4/28/2021 |
Generic Drug Development; Labeling |
Generic Drugs Forum 2021: Panel Discussion 4 |
Conference/Workshop |
4/28/2021 |
Generic Drug Development |
Addressing Common Challenges in BE Studies Due to COVID-19: OGD’s Approach |
Conference/Workshop |
4/28/2021 |
Generic Drug Development |
Insights from Records Requests under §704(a)(4) of the FD&C Act in lieu of Pre-Approval Inspections |
Conference/Workshop |
4/28/2021 |
Generic Drug Development |
Generic Drugs Forum 2021: Panel Discussion 5 |
Conference/Workshop |
4/28/2021 |
Generic Drug Development |
Mid-Review Cycle Meeting Overview |
Conference/Workshop |
4/28/2021 |
Generic Drug Development; FDA Meetings/Communications |
Information to Include with Cover Letters |
Conference/Workshop |
4/28/2021 |
Generic Drug Development; FDA Meetings/Communications |
Application Communications – Quality Assessment Perspective |
Conference/Workshop |
4/28/2021 |
Generic Drug Development; Drug Quality |
Generic Drugs Forum 2021: Panel Discussion 6 |
Conference/Workshop |
4/28/2021 |
Generic Drug Development |
Fostering Innovation Through OPQ’s Emerging Technology Program |
Conference/Workshop |
4/28/2021 |
Generic Drug Development |
Lab Science to Support Generic Complex Drug Product Assessment |
Conference/Workshop |
4/28/2021 |
Generic Drug Development |
Assessment of Extractables/Leachables Data in ANDA Submissions |
Conference/Workshop |
4/28/2021 |
Generic Drug Development; Drug Quality |
Generic Drugs Forum 2021: Panel Discussion 7 |
Conference/Workshop |
4/28/2021 |
Generic Drug Development |
Biopharmaceutics Risk Assessment to Guide Dissolution Method Development for Solid Oral Dosage Forms |
Conference/Workshop |
4/28/2021 |
Generic Drug Development; Drug Quality |
Integrated Manufacturing Assessment: Expectations |
Conference/Workshop |
4/28/2021 |
Generic Drug Development; Drug Quality |
Building a Better Sterility Assurance Application |
Conference/Workshop |
4/28/2021 |
Generic Drug Development; Drug Quality |
Generic Drugs Forum 2021: Panel Discussion 8 |
Conference/Workshop |
4/28/2021 |
Generic Drug Development |
Postmarketing Safety and Surveillance of Generic Drugs Update |
Conference/Workshop |
4/28/2021 |
Generic Drug Development |
Premarket Review of Expedited Serious Adverse Event Reports of BA/BE Studies |
Conference/Workshop |
4/28/2021 |
Generic Drug Development; Safety |
Update on Shared System REMS for Generic Drug |
Conference/Workshop |
4/28/2021 |
Generic Drug Development; Safety |
ANDA Postapproval Changes: Best Practices and Strategies to Avoid Common Quality Assessment Issues |
Conference/Workshop |
4/28/2021 |
Generic Drug Development |
Generic Drugs Forum 2021: Panel Discussion 9 |
Conference/Workshop |
4/28/2021 |
Generic Drug Development |
Drug Master File (DMF) and Drug Substance Question and Answer Webinar Following March 3-4, 2021 Workshop |
Webinar |
4/9/2021 |
Drug Master Files |
FDA Safety Report Type Flag Requirement for FAERS Submissions |
Webinar |
2/19/2021 |
Regulatory Submissions; Safety |
Oncology Therapy Development Workshop: Pivotal Steps and Avoiding Pitfalls for Start-ups |
Conference/Workshop |
3/30/2021 |
New Drug Development; Clinical Trials and Research |
Oncology Center of Excellence Introduction and Overview of the Oncology Therapy Development Workshop |
Conference/Workshop |
3/30/2021 |
New Drug Development; Clinical Trials and Research |
Innovation Mindset – Advancing Science to Therapies |
Conference/Workshop |
3/30/2021 |
New Drug Development; Clinical Trials and Research |
FDA Oncology Drug Development Overview – Past to Present |
Conference/Workshop |
3/30/2021 |
New Drug Development; Clinical Trials and Research |
Federal Resources for Innovative Cancer Startups: More Than Just Funding |
Conference/Workshop |
3/30/2021 |
New Drug Development; Clinical Trials and Research |
Best Practices for Venture Capital Fundraising: Learn How Early-stage VCs Think |
Conference/Workshop |
3/30/2021 |
New Drug Development; Clinical Trials and Research |
Funding Sources Panel Discussion |
Conference/Workshop |
3/30/2021 |
New Drug Development; Clinical Trials and Research |
Building Your Network and Value to Obtain External Input Prior to Interacting with FDA |
Conference/Workshop |
3/30/2021 |
New Drug Development; Clinical Trials and Research |
Assembling the Best Team to Navigate through Preclinical Development |
Conference/Workshop |
3/30/2021 |
New Drug Development; Clinical Trials and Research |
Consulting Companies and FDA Limitations Panel Discussion |
Conference/Workshop |
3/30/2021 |
New Drug Development; Clinical Trials and Research |
CMC Considerations for CAR T Cell Product Development |
Conference/Workshop |
3/30/2021 |
New Drug Development; Clinical Trials and Research |
CMC Considerations for Oncolytic Viral Product Development |
Conference/Workshop |
3/30/2021 |
New Drug Development; Clinical Trials and Research |
Preclinical Considerations for Cell and Gene Therapy Products, an FDA Perspective |
Conference/Workshop |
3/30/2021 |
New Drug Development; Clinical Trials and Research |
FDA’s Clinical Regulatory Perspective: Designing First-In-Human Trial for Cellular and Gene Therapy |
Conference/Workshop |
3/30/2021 |
New Drug Development; Clinical Trials and Research |
Oncology Therapy Development Workshop Overview, Day Two |
Conference/Workshop |
3/30/2021 |
New Drug Development; Clinical Trials and Research |
Chemistry and Manufacturing Requirements for Early Clinical Development: What’s in there? Prove it. |
Conference/Workshop |
3/30/2021 |
New Drug Development; Clinical Trials and Research |
CMC Considerations for Biotechnology Product Development: A Regulatory Perspective |
Conference/Workshop |
3/30/2021 |
New Drug Development; Clinical Trials and Research |
Getting to First-in-Human for Small Molecules and Biologics |
Conference/Workshop |
3/30/2021 |
New Drug Development; Clinical Trials and Research |
Designing First-In-Human Trials for Small Molecules and Biologics |
Conference/Workshop |
3/30/2021 |
New Drug Development; Clinical Trials and Research |
Planning for Co-development of Companion Diagnostics |
Conference/Workshop |
3/30/2021 |
New Drug Development; Clinical Trials and Research |
Clinical Development of Radiopharmaceuticals a Theranostic Pairs and Dosimetry Considerations |
Conference/Workshop |
3/30/2021 |
New Drug Development; Clinical Trials and Research |
Getting the Best Dose: The Clinical Pharmacology Studies that Help Achieve this Goal |
Conference/Workshop |
3/30/2021 |
New Drug Development; Clinical Trials and Research |
Oncology Center of Excellence Introduction and Overview of the Oncology Therapy Development Workshop: Panel Discussion |
Conference/Workshop |
3/30/2021 |
New Drug Development; Clinical Trials and Research |
Drug Master File (DMF) and Drug Substance Workshop |
Webinar |
3/3/2021 |
Drug Master Files |
Regulatory Perspectives for Development of Drugs for Treatment of NASH |
Webinar |
1/29/2021 |
New Drug Development; Clinical Trials and Research |
OTC Monograph Reform in the CARES Act: Safety Orders |
Webinar |
1/27/2021 |
OTC Drug Regulation |
CDER Compliance Conference |
Conference/Workshop |
1/14/2021 |
Compliance, Import/Export; Compounding; DSCSA; Safety |
Compounding: Cleanrooms and Cleanroom Behaviors: Why they Matter |
Conference/Workshop |
1/14/2021 |
Compliance, Import/Export; Compounding |
Enhanced Drug Distribution Security – Drug Supply Chain Security Act (DSCSA) Implementation Updates |
Conference/Workshop |
1/14/2021 |
Compliance, DSCSA |
A Glance at Drug Importation Requirements |
Conference/Workshop |
1/14/2021 |
Compliance, Import/Export; Compounding |
Risk Evaluation and Mitigation Strategies (REMS) Compliance Program |
Conference/Workshop |
1/14/2021 |
Compliance, Safety |
Diversity in Clinical Trials: Learn about Enrollment Trends and Resources from FDA |
Webinar |
12/16/2020 |
Clinical Trials and Research |
SEND for CBER, What You Need to Know |
Webninar |
12/4/2020 |
Regulatory Submissions |
Guidance for Industry: Referencing Approved Drug Products in ANDA Submissions |
Webinar |
11/20/2020 |
Generic Drug Development |
Office of Prescription Drug Promotion - Core Launch Review Process |
Webinar |
11/20/2020 |
Marketing |
Bridging the Gap – Promoting Safe and Effective Prescription Drug Use in Geriatric Patients |
Webinar |
11/13/2020 |
Labeling |
Office of New Drug (OND) Research: Seeking Collaborators, Funding Opportunities Available |
Webinar |
11/6/2020 |
New Drug Development |
Celebrating 40 Years: An In-Depth Examination of the FDA Orange Book |
Conference/Workshop |
10/27/2020 |
Generic Drug Development; New Drug Development; Orange Book |
Opening Remarks and FDA's Orange Book: A Historical Review of 40 Years |
Conference/Workshop |
10/27/2020 |
Generic Drug Development; New Drug Development; Orange Book |
Orange Book 101: An Overview of FDA's Orange Book |
Conference/Workshop |
10/27/2020 |
Generic Drug Development; New Drug Development; Orange Book |
How to Update Orange Book Information |
Conference/Workshop |
10/27/2020 |
Generic Drug Development; New Drug Development; Orange Book |
How to Update Orange Book Information – Panel Discussion |
Conference/Workshop |
10/27/2020 |
Generic Drug Development; New Drug Development; Orange Book |
An Overview of FDA's Patent Listing Process |
Conference/Workshop |
10/27/2020 |
Generic Drug Development; New Drug Development; Orange Book |
Changes to Orange Book Patent Information |
Conference/Workshop |
10/27/2020 |
Generic Drug Development; New Drug Development; Orange Book |
Orange Book Patent Information – Panel Discussion |
Conference/Workshop |
10/27/2020 |
Generic Drug Development; New Drug Development; Orange Book |
The Patent Information Dispute Process |
Conference/Workshop |
10/27/2020 |
Generic Drug Development; New Drug Development; Orange Book |
Best Practices for 505(b)(2) and ANDA Applicants |
Conference/Workshop |
10/27/2020 |
Generic Drug Development; New Drug Development; Orange Book |
Patent Dispute and Best Practices for 505(b)(2) and ANDA Applicants – Panel Discussion |
Conference/Workshop |
10/27/2020 |
Generic Drug Development; New Drug Development; Orange Book |
Orange Book Exclusivity: An Introduction and Overview |
Conference/Workshop |
10/27/2020 |
Generic Drug Development; New Drug Development; Orange Book |
Orange Book Exclusivity: Part I - NCE and 3-Year |
Conference/Workshop |
10/27/2020 |
Generic Drug Development; New Drug Development; Orange Book |
Orange Book Exclusivity – Panel Discussion |
Conference/Workshop |
10/27/2020 |
Generic Drug Development; New Drug Development; Orange Book |
Orange Book Exclusivity: Part II - Pediatric, Orphan, and GAIN |
Conference/Workshop |
10/27/2020 |
Generic Drug Development; New Drug Development; Orange Book |
Orange Book Exclusivity: Part III - 180-Day and Competitive Generic Therapy Exclusivities |
Conference/Workshop |
10/27/2020 |
Generic Drug Development; New Drug Development; Orange Book |
Orange Book Exclusivity – Panel Discussion |
Conference/Workshop |
10/27/2020 |
Generic Drug Development; New Drug Development; Orange Book |
Orange Book: An Overview of Therapeutic Equivalence |
Conference/Workshop |
10/27/2020 |
Generic Drug Development; New Drug Development; Orange Book |
Referencing Approved Drug Products in ANDA Submissions |
Conference/Workshop |
10/27/2020 |
Generic Drug Development; New Drug Development; Orange Book |
Orange Book: Looking Towards the Future |
Conference/Workshop |
10/27/2020 |
Generic Drug Development; New Drug Development; Orange Book |
Closing Remarks |
Conference/Workshop |
10/27/2020 |
Generic Drug Development; New Drug Development; Orange Book |
New Approaches for an Integrated Nonclinical-Clinical QT/Proarrhythmic Risk Assessment |
Webinar |
10/15/2020 |
Drug Development; Clinical Trials and Research |
Drug Registration and Listing Workshop |
Conference/Workshop |
10/8/2020 |
Registration and Listing |
Drug Registration and Listing Workshop: Labeler Code Request |
Conference/Workshop |
10/8/2020 |
Registration and Listing |
Drug Registration and Listing Workshop: Establishment Registration |
Conference/Workshop |
10/8/2020 |
Registration and Listing |
Drug Registration and Listing Workshop: Drug Listing |
Conference/Workshop |
10/8/2020 |
Registration and Listing |
Drug Registration and Listing Workshop: 503B Compounder Product Reporting Using CDERDirect |
Conference/Workshop |
10/8/2020 |
Registration and Listing |
Drug Registration and Listing Workshop: Establishment Registration and Drug Listing Compliance Program |
Conference/Workshop |
10/8/2020 |
Registration and Listing |
Overview of the Guidance for Industry: Control of Nitrosamine Impurities in Human Drugs |
Webinar |
10/2/2020 |
Drug Quality |
Advancing Innovative Science in Generic Drug Development Workshop |
Conference/Workshop |
9/29/2020 |
Generic Drug Development |
Dr. Hahn's Remarks to “Advancing Innovative Science in Generic Drug Development” Workshop 9/29/2020 |
Conference/Workshop |
9/29/2020 |
Generic Drug Development |
Update on GDUFA Science and Research |
Conference/Workshop |
9/29/2020 |
Generic Drug Development |
March 2020 Transition Under the BPCI Act: Impact on Generics |
Conference/Workshop |
9/29/2020 |
Generic Drug Development |
Related Impurities Assessment Considerations for APIs in the Generic Complex Peptide Products |
Conference/Workshop |
9/29/2020 |
Generic Drug Development |
Non-clinical Evaluation of Immunogenicity Risk of Generic Complex Peptide Products |
Conference/Workshop |
9/29/2020 |
Generic Drug Development |
Panel Discussion on Method Development / Validations for Non-traditional Analytical Methods |
Conference/Workshop |
9/29/2020 |
Generic Drug Development |
Developing and Validating Advanced Microscopy Methods for Supporting Complex Product Equivalence |
Conference/Workshop |
9/29/2020 |
Generic Drug Development |
Developing & Validating Commonly Employed Particle Sizing Methods to Support BE and Product Quality |
Conference/Workshop |
9/29/2020 |
Generic Drug Development |
Quantitative Methods for Determining Equivalence of Particle Size Distributions |
Conference/Workshop |
9/29/2020 |
Generic Drug Development |
Panel for Advanced Analytical and Statistical Methods for Assessing Particle Size Distributions |
Conference/Workshop |
9/29/2020 |
Generic Drug Development |
Assessment of Complex Drug Product – Physicochemical Characteristics to Support In Vitro BE Studies |
Conference/Workshop |
9/29/2020 |
Generic Drug Development |
In Vitro Release Testing for Complex Generics: A Bioequivalence Perspective |
Conference/Workshop |
9/29/2020 |
Generic Drug Development |
In Vitro Bioequivalence Studies of Topical Drug Products: Challenges and Promises of IVRT and IVPT |
Conference/Workshop |
9/29/2020 |
Generic Drug Development |
Panel on Development and Validation Considerations for Drug Release and Permeation Testing |
Conference/Workshop |
9/29/2020 |
Generic Drug Development |
Formulation Assessments: General Q1/Q2 Inquiries to Supporting Complex Excipient Sameness |
Conference/Workshop |
9/29/2020 |
Generic Drug Development |
Calculating Maximum Daily Dose (MDD) for Orally Administered Drug Products |
Conference/Workshop |
9/29/2020 |
Generic Drug Development |
What’s New in the Inactive Ingredient Database (IID)? |
Conference/Workshop |
9/29/2020 |
Generic Drug Development |
Local Toxicity Considerations for Qualifying Excipients in Generic Drugs |
Conference/Workshop |
9/29/2020 |
Generic Drug Development |
Panel on Excipient and Formulation Considerations |
Conference/Workshop |
9/29/2020 |
Generic Drug Development |
In Vitro Studies for Alternative BE Approaches to Comparative Clinical Endpoint BE Studies |
Conference/Workshop |
9/29/2020 |
Generic Drug Development |
The Potential of PK BE Studies in Detecting Regional Deposition with Orally Inhaled Drugs |
Conference/Workshop |
9/29/2020 |
Generic Drug Development |
Regional Deposition and Systemic Pharmacokinetic Data of OINDPs with Modeling and Simulation |
Conference/Workshop |
9/29/2020 |
Generic Drug Development |
Panel on Future Directions, Emerging Technology, and Current Thinking on Alternative BE Approaches |
Conference/Workshop |
9/29/2020 |
Generic Drug Development |
Topical Dosage Forms: Emerging Insights and Implications for Bioequivalence Approaches |
Conference/Workshop |
9/29/2020 |
Generic Drug Development |
In Vivo Dermal Microperfusion & Microdialysis Bioequivalence Approaches |
Conference/Workshop |
9/29/2020 |
Generic Drug Development |
Non-Invasive Raman Spectroscopy-Based Bioequivalence Approaches |
Conference/Workshop |
9/29/2020 |
Generic Drug Development |
Panel on Topical Dermatologic Products |
Conference/Workshop |
9/29/2020 |
Generic Drug Development |
PBPK to Guide Study Design and Product Development for Generic Dermatological Products |
Conference/Workshop |
9/29/2020 |
Generic Drug Development |
Model-Informed and Model-Integrated Approach in BE Assessment of Long-Acting Injectable Products |
Conference/Workshop |
9/29/2020 |
Generic Drug Development |
Panel on Emerging Use of Modeling and Simulation for Bioequivalence |
Conference/Workshop |
9/29/2020 |
Generic Drug Development |
Biopharmaceutics Classification System Class 3 Waiver |
Conference/Workshop |
9/29/2020 |
Generic Drug Development |
Using PBPK Absorption Modeling to Support Biopharmaceutics Classification System Class 3 Drug Waiver |
Conference/Workshop |
9/29/2020 |
Generic Drug Development |
Alternatives to f2 Testing for Dissolution Similarity – f2 Bootstrapping and MSD Method |
Conference/Workshop |
9/29/2020 |
Generic Drug Development |
Panel on Practical Considerations in the Study Design and Data Evaluation Recommended in PSGs |
Conference/Workshop |
9/29/2020 |
Generic Drug Development |
A Closer Look into the Nasogastric and Gastric Feeding Tube Study Recommendations |
Conference/Workshop |
9/29/2020 |
Generic Drug Development |
In Vitro Enteral (Nasogastric and Gastric) Feeding Tube Testing of Generic Drugs: Case Studies |
Conference/Workshop |
9/29/2020 |
Generic Drug Development |
Practical Considerations for Bioequivalence of GI Locally-Acting Products |
Conference/Workshop |
9/29/2020 |
Generic Drug Development |
Panel on In Vitro Feeding Tube Testing and GI Locally-Acting Products |
Conference/Workshop |
9/29/2020 |
Generic Drug Development |
Cannabis Clinical Research: Drug Master Files (DMFs) & Quality Considerations |
Webinar |
9/16/2020 |
Drug Master Files |
Real-world Evidence for Drugs, Biologics, and Devices - REdI 2020 |
Conference/Workshop |
8/25/2020 |
New Drug Development; Real World Evidence; Postapproval |
Restructure of the Office of New Drugs (OND) - REdI 2020 |
Conference/Workshop |
8/25/2020 |
New Drug Development; NDA; Postapproval |
So, Your NDA Was Approved – Now What?! Post-approval Responsibilities and Obligations- REdI 2020 |
Conference/Workshop |
8/25/2020 |
New Drug Development; NDA; Postapproval |
Overview of Postmarketing Drug Safety Reporting Requirements - REdI 2020 |
Conference/Workshop |
8/25/2020 |
New Drug Development; NDA; Postapproval; Safety |
Drug Shortages - REdI 2020 |
Conference/Workshop |
8/25/2020 |
New Drug Development; NDA; Postapproval; Drug Shortages |
Enhanced Drug Distribution Security – DSCSA Implementation Updates - REdI 2020 |
Conference/Workshop |
8/25/2020 |
New Drug Development; NDA; Postapproval; DSCSA |
CDER Export Certificate Program - REdI 2020 |
Conference/Workshop |
8/25/2020 |
New Drug Development; NDA; Postapproval; Import/Export |
SBIA Program Overview - REdI 2020 |
Conference/Workshop |
8/25/2020 |
New Drug Development; NDA; Postapproval; Resources |
Post-Approval Submission of Promotional Materials to the OPDP - REdI 2020 |
Conference/Workshop |
8/25/2020 |
New Drug Development; NDA; Postapproval; Marketing |
Requirement for Electronic Submission of an Application and Study Data - REdI 2020 |
Conference/Workshop |
8/25/2020 |
New Drug Development; NDA; Postapproval; Regulatory Submissions |
Overview of Post-approval Chemistry, Manufacture, and Controls (CMC) Changes to an NDA - REdI 2020 |
Conference/Workshop |
8/25/2020 |
New Drug Development; NDA; Postapproval; Drug Quality |
Lifecycle Changes to Chemistry, Manufacture, and Controls in NDAs - REdI 2020 |
Conference/Workshop |
8/25/2020 |
New Drug Development; NDA; Postapproval; Drug Quality |
Post-approval Considerations for Changes to Manufacturing Process and Facilities - REdI 2020 |
Conference/Workshop |
8/25/2020 |
New Drug Development; NDA; Postapproval; Drug Quality |
Questions and Panel Discussion – Post-approval CMC and Manufacturing - REdI 2020 |
Conference/Workshop |
8/25/2020 |
New Drug Development; NDA; Postapproval; Drug Quality |
FDA Drug Manufacturing Inspections - REdI 2020 |
Conference/Workshop |
8/25/2020 |
New Drug Development; NDA; Postapproval; Inspections |
Regulatory Education for Industry (REdI) Annual Conference - 2020 |
Conference/Workshop |
8/25/2020 |
New Drug Development; NDA; Postapproval |
Bioanalysis of Endogenous Compounds in PK BE Studies in ANDAs - Bioanalysis |
Conference/Workshop |
6/30/2020 |
Generic Drug Development |
Bioanalysis of the Dried Blood Spot (DBS) by Mass Spectrometry for Clinical Studies -Bioanalysis |
Conference/Workshop |
6/30/2020 |
Generic Drug Development |
Bioanalysis of Unstable Analytes in Pharmacokinetic BE Studies for ANDAs - Bioanalysis |
Conference/Workshop |
6/30/2020 |
Generic Drug Development |
Bioanalytical Method Validation: History, Process, and Regulatory Perspectives - Bioanalysis |
Conference/Workshop |
6/30/2020 |
Generic Drug Development |
Case Study: Bioanalytical Approaches to Mitigate Issues during a BE Inspection - Bioanalysis |
Conference/Workshop |
6/30/2020 |
Generic Drug Development |
Common Deficiencies for Study Sample Reanalysis in PK BE for ANDAs - Bioanalysis |
Conference/Workshop |
6/30/2020 |
Generic Drug Development |
Considerations on ex vivo Conversion of Prodrugs during Bioanalysis - Bioanalysis |
Conference/Workshop |
6/30/2020 |
Generic Drug Development |
CREST Site Selection Model Overview - Bioanalysis |
Conference/Workshop |
6/30/2020 |
Generic Drug Development |
Keynote - Bioanalysis |
Conference/Workshop |
6/30/2020 |
Generic Drug Development |
Office of Clinical Pharmacology (OCP): Biosimilars - Bioanalysis |
Conference/Workshop |
6/30/2020 |
Generic Drug Development |
Office of Clinical Pharmacology (OCP): Drugs and Biologics - Bioanalysis |
Conference/Workshop |
6/30/2020 |
Generic Drug Development |
Office of Clinical Pharmacology (OCP): Panel Discussion - Bioanalysis |
Conference/Workshop |
6/30/2020 |
Generic Drug Development |
Office of Generic Drugs Panel Discussion - Bioanalysis |
Conference/Workshop |
6/30/2020 |
Generic Drug Development |
Office of Study Integrity and Surveillance Session (OSIS) Panel Discussion - Bioanalysis |
Conference/Workshop |
6/30/2020 |
Generic Drug Development |
Overview of Immunogenicity Inspections - Bioanalysis |
Conference/Workshop |
6/30/2020 |
Generic Drug Development |
Panel Discussion - Bioanalysis |
Conference/Workshop |
6/30/2020 |
Generic Drug Development |
Regulated Bioanalysis for Small Molecules - Bioanalysis |
Conference/Workshop |
6/30/2020 |
Generic Drug Development |
Regulated Bioanalysis of Large Molecules - Bioanalysis |
Conference/Workshop |
6/30/2020 |
Generic Drug Development |
Regulatory Education for Industry: Regulated Bioanalysis Workshop: Requirements and Expectations |
Conference/Workshop |
6/30/2020 |
Generic Drug Development |
What Meta-analysis Can Tell You about the Performance of Bioanalytical Methods - Bioanalysis |
Conference/Workshop |
6/30/2020 |
Generic Drug Development |
Keynote: Pharmaceutical Quality: A Global Priority (CDER) (1/15) Global Quality |
Webinar |
7/23/2020 |
Drug Quality; International |
An International Commitment to Pharmaceutical Quality (2/15) Global Quality |
Webinar |
7/23/2020 |
Drug Quality; International |
Manufacturing Assessment and Application Action (3/15) Global Quality |
Webinar |
7/23/2020 |
Drug Quality; International |
Pre-Approval Inspections and Alternative Approaches to Facility Assessment (4/15) Global Quality |
Webinar |
7/23/2020 |
Drug Quality; Inspections; International |
An Overview of Pre-License Inspections for Biotech Products (5/15) Global Quality |
Webinar |
7/23/2020 |
Drug Quality; Inspections; International |
Panel Discussion (6/15) Global Quality |
Webinar |
7/23/2020 |
Drug Quality; Inspections; International |
FDA’s International Mission and the Global Manufacturing Landscape (7/15) Global Quality |
Webinar |
7/23/2020 |
Drug Quality; International |
Quality Management Maturity: FDA Vision & Expectations (8/15) Global Quality |
Webinar |
7/23/2020 |
Drug Quality; International |
Major Issues and Facilities in Drug Master Files (9/15) Global Quality |
Webinar |
7/23/2020 |
Drug Quality; Drug Master Files; International |
Pharmaceutical Quality Policies: What You Need to Know (10/15) Global Quality |
Webinar |
7/23/2020 |
Drug Quality; International |
Panel Discussion (11/15) Global Quality |
Webinar |
7/23/2020 |
Drug Quality; Drug Master Files; International |
FDA’s International Office and the Pharmaceutical Quality Mission (12/15) Global Quality |
Webinar |
7/23/2020 |
Drug Quality; International |
The State of Pharmaceutical Quality: Surveillance Findings (13/15) Global Quality |
Webinar |
7/23/2020 |
Drug Quality; International |
Successfully Implementing Advanced Manufacturing (14/15) Global Quality |
Webinar |
7/23/2020 |
Drug Quality; International |
Panel Discussion (15/15) Global Quality |
Webinar |
7/23/2020 |
Drug Quality; International |
A Pharmaceutical Quality Webinar for Global Stakeholders |
Webinar |
7/23/2020 |
Drug Quality; International |
CDER SEND Common Issues and Policy Update |
Webinar |
6/15/2020 |
Regulatory Submissions |
Best Practices for Proprietary Name Design – Pharmacovigilance |
Conference/Workshop |
6/9/2020 |
Safety |
Combination Products: Reporting Device Information and Malfunctions - Pharmacovigilance |
Conference/Workshop |
6/9/2020 |
Safety |
Considerations for REMS Surveys and Assessments: Planning and Reporting - Pharmacovigilance |
Conference/Workshop |
6/9/2020 |
Safety |
Designing User Interfaces to Prevent Medication Errors – Pharmacovigilance |
Conference/Workshop |
6/9/2020 |
Safety |
Development of Shared System REMS & Implications of the Appropriations Act - Pharmacovigilance |
Conference/Workshop |
6/9/2020 |
Safety |
Digital IND Safety Reporting - Pharmacovigilance |
Conference/Workshop |
6/9/2020 |
Safety; IND |
Division of Risk Management: Overview of Review Activities and REMS - Pharmacovigilance |
Conference/Workshop |
6/9/2020 |
Safety |
FDA Adverse Event Reporting System (FAERS) Overview - Pharmacovigilance |
Conference/Workshop |
6/9/2020 |
Safety |
FDA's Sentinel Initiative - Pharmacovigilance |
Conference/Workshop |
6/9/2020 |
Safety |
ICSR Data Quality of Coding: Products, Adverse Events and Medication Errors - Pharmacovigilance |
Conference/Workshop |
6/9/2020 |
Safety |
Keynote – Pharmacovigilance and Risk Management Conference |
Conference/Workshop |
6/9/2020 |
Safety |
Postmarket Safety Surveillance: Tools, Methods, and Benefit-Risk Framework - Pharmacovigilance |
Conference/Workshop |
6/9/2020 |
Safety |
Preventing Medication Errors: Lessons Learned from Postmarket Safety Surveillance– Pharmacovigilance |
Conference/Workshop |
6/9/2020 |
Safety |
Process for Reviewing Nonproprietary Name Suffix for Biological Products – Pharmacovigilance |
Conference/Workshop |
6/9/2020 |
Safety |
Questions and Discussion – Pharmacovigilance |
Conference/Workshop |
6/9/2020 |
Safety |
REMS Integration Initiatives - Pharmacovigilance |
Conference/Workshop |
6/9/2020 |
Safety |
Pharmacovigilance and Risk Management Conference – New Approaches, Tools, and Technologies |
Conference/Workshop |
6/9/2020 |
Drug Development; Drug Safety |
Monograph reform is here! Learn what to expect and how to prepare. |
Webinar |
5/29/2020 |
Regulatory Submissions; OTC Drug Regulation |
Still submitting paper to CDER? Send electronically with CDER’s NextGen Portal instead! |
Webinar |
5/26/2020 |
Regulatory Submissions |
Conducting Clinical Trials During the COVID-19 Public Health Emergency |
Webinar |
4/30/2020 |
New Drug Development |
Postmarketing Drug Safety Compliance: 2019 Inspection Findings |
Webinar |
4/29/2020 |
Safety; Inspections |
Updates on FDA’s Drug-Drug Interaction Final Guidances |
Webinar |
4/24/2020 |
New Drug Development; IND |
Generic Drugs Forum - April 15&16, 2020 |
Conference/Workshop |
4/15/2020 |
Generic Drug Development; Drug Quality |
ANDA Program Performance Review and Tips (8/16) Generic Drugs Forum |
Conference/Workshop |
4/15/2020 |
Generic Drug Development; Drug Quality |
Application Case Studies on FDA’s Action Letter Timing (16/16) Generic Drugs Forum |
Conference/Workshop |
4/15/2020 |
Generic Drug Development; Drug Quality |
Common CMC (Quality) Issues and How to Avoid Them Part I (12/16) Generic Drugs Forum |
Conference/Workshop |
4/15/2020 |
Generic Drug Development; Drug Quality |
Common CMC (Quality) Issues and How to Avoid Them Part II (14/16) Generic Drugs Forum |
Conference/Workshop |
4/15/2020 |
Generic Drug Development; Drug Quality |
Current Global Generic Drug Landscape (10/16) Generic Drugs Forum |
Conference/Workshop |
4/15/2020 |
Generic Drug Development; Drug Quality |
Electronic Submission of an ANDA Application and Study Data (7/16) Generic Drugs Forum |
Conference/Workshop |
4/15/2020 |
Generic Drug Development; Drug Quality |
Facility Readiness: GMPs, Quality Assessments, and Compliance Trends (15/16) Generic Drugs Forum |
Conference/Workshop |
4/15/2020 |
Generic Drug Development; Drug Quality |
Generic Combination Products: Assessment and Regulatory Update (14/16) Generic Drugs Forum |
Conference/Workshop |
4/15/2020 |
Generic Drug Development; Drug Quality |
Generic Drug Labeling: Recommendations for High-Quality Submissions (4/28) Generic Drugs Forum |
Conference/Workshop |
4/15/2020 |
Generic Drug Development; Drug Quality |
ICH Q12 Guidance and Emerging Technology Program (11/16) Generic Drugs Forum |
Conference/Workshop |
4/15/2020 |
Generic Drug Development; Drug Quality |
Keynote from the Office of Pharmaceutical Quality (OPQ) (2/16) Generic Drugs Forum |
Conference/Workshop |
4/15/2020 |
Generic Drug Development; Drug Quality |
Keynote: Generic Drug Program Update (1/16) Generic Drugs Forum |
Conference/Workshop |
4/15/2020 |
Generic Drug Development; Drug Quality |
New Programs and Requirements Under FDARA (5/16) Generic Drugs Forum |
Conference/Workshop |
4/15/2020 |
Generic Drug Development; Drug Quality |
Pre-ANDA Interactions with the FDA (6/16) Generic Drugs Forum |
Conference/Workshop |
4/15/2020 |
Generic Drug Development; Drug Quality |
Product Specific Guidances (PSGs) (3/16) Generic Drugs Forum |
Conference/Workshop |
4/15/2020 |
Generic Drug Development; Drug Quality |
The Importance of Generic Drug Pharmacovigilance (9/16) Generic Drugs Forum |
Conference/Workshop |
4/15/2020 |
Generic Drug Development; Drug Quality |
Learn About ClinicalTrials.gov Modernization and How to Provide Input |
Webinar |
3/6/2020 |
Clinical Trials and Research |
Recent Revisions to the ANDA Prioritization MAPP |
Webinar |
1/30/2020 |
Generic Drug Development |
Improving Regulatory Communication via the CDER NextGen Portal |
SBIA Chronicles Podcast |
12/29/2019 |
Regulatory Submissions |
Improving Regulatory Communication via the CDER NextGen Portal |
SBIA Chronicles |
12/19/2019 |
Regulatory Submissions |
What is new with Forms FDA 3542a and 3542? |
Webinar |
12/11/2019 |
Regulatory Submissions |
What is new with Forms FDA 3542a and 3542 |
Webinar |
12/5/2019 |
Regulatory Submissions |
2019 CDER Prescription Drug Labeling Conference - December 4-5, 2019 |
Conference/Workshop |
12/4/2019 |
New Drug Development; Labeling |
A Recipe for Clinical Pharmacology Information in Labeling (1/19) |
Conference/Workshop |
12/4/2019 |
Labeling |
Adverse Reaction Information in Prescribing Information (3/19) |
Conference/Workshop |
12/4/2019 |
Labeling |
Drug Product Nomenclature (15/19) |
Conference/Workshop |
12/4/2019 |
Labeling |
Improving the Accuracy of SPL Submissions “The Missing LOINC” (9/19) |
Conference/Workshop |
12/4/2019 |
Labeling |
Indications and Usage & Drug Abuse and Dependence Sections of Labeling (2/19) |
Conference/Workshop |
12/4/2019 |
Labeling |
Instructions for Use (IFU) Content and Format Draft Guidance (13/19) |
Conference/Workshop |
12/4/2019 |
Labeling |
Labeling Case Study: Transformation of an Indication (6/19) |
Conference/Workshop |
12/4/2019 |
Labeling |
Labeling Finalization: Final Check of Prescribing Information (8/19) |
Conference/Workshop |
12/4/2019 |
Labeling |
Labeling for Biological Products (11/19) |
Conference/Workshop |
12/4/2019 |
Labeling |
Panel Questions and Discussion (10/19) |
Conference/Workshop |
12/4/2019 |
Labeling |
Panel Questions and Discussion (16/19) |
Conference/Workshop |
12/4/2019 |
Labeling |
Panel Questions and Discussion (19/19) |
Conference/Workshop |
12/4/2019 |
Labeling |
Panel Questions and Discussion (7/19) |
Conference/Workshop |
12/4/2019 |
Labeling |
Pediatric Information In Prescribing Information (4/19) |
Conference/Workshop |
12/4/2019 |
Labeling |
Prescribing Information and Carton/Container Labeling Consistency (18/19) |
Conference/Workshop |
12/4/2019 |
Labeling |
Product Title & Initial US Approval in the Highlights Section (14/19) |
Conference/Workshop |
12/4/2019 |
Labeling |
Safety Considerations for Container Labels and Carton Labeling (17/19) |
Conference/Workshop |
12/4/2019 |
Labeling |
The Pregnancy and Lactation Labeling Rule: Four Years In — What’s next? (5/19) |
Conference/Workshop |
12/4/2019 |
Labeling |
Voluntary PLR Conversions and Updating Prescribing Information (1/19) |
Conference/Workshop |
12/4/2019 |
Labeling |
2019 CDER Prescription Drug Labeling Conference |
Conference/Workshop |
12/4/2019 |
Labeling |
FDA Study Data Technical Conformance Guide v4.4 |
Webinar |
11/22/2019 |
Regulatory Submissions |
Clinical Investigator Training Course |
Conference/Workshop |
11/12/2019 |
New Drug Development |
Technical Specifications for Submitting Data for QT Studies |
Webinar |
11/8/2019 |
Regulatory Submissions |
Submitting IND Safety Reports to FDA Adverse Event Reporting System (FAERS) |
Webinar |
11/1/2019 |
Safety; IND; Regulatory Submissions |
OPDP Electronic Submissions – Common Errors in eCTD and How to Avoid Them |
Webinar |
10/25/2019 |
Regulatory Submissions; Marketing |
Compliance Program and Case Study (7/8) Registration and Listing |
Conference/Workshop |
10/22/2019 |
Registration and Listing |
Electronic Drug Registration and Listing Using CDER Direct |
Conference/Workshop |
10/22/2019 |
Registration and Listing |
Establishment Registration and Labeler Code Requests (3/8) Registration and Listing |
Conference/Workshop |
10/22/2019 |
Registration and Listing |
Keynote from the Drug Registration and Listing Staff (2/8) Registration and Listing |
Conference/Workshop |
10/22/2019 |
Registration and Listing |
Listing Certification and Inactivation (6/8) Registration and Listing |
Conference/Workshop |
10/22/2019 |
Registration and Listing |
NDC Reservation, Listing, 503B Compounded Product (5/8) Registration and Listing |
Conference/Workshop |
10/22/2019 |
Registration and Listing |
Panel Questions and Discussion (4/8) Drug Registration and Listing Using CDER Direct |
Conference/Workshop |
10/22/2019 |
Registration and Listing |
Panel Questions and Discussion (8/8) Registration and Listing |
Conference/Workshop |
10/22/2019 |
Registration and Listing |
Welcome from CDER’s Office of Compliance (1/8) Registration and Listing |
Conference/Workshop |
10/22/2019 |
Registration and Listing |
Application Manufacturing Assessment (4/33) Quality |
Conference/Workshop |
10/16/2019 |
Drug Quality |
Assessment of the Multi-Attribute Method (MAM) Substance (23/33) Quality |
Conference/Workshop |
10/16/2019 |
Drug Quality |
Biosimilars and Interchangeables - Regulatory Highlights (27/33) Quality |
Conference/Workshop |
10/16/2019 |
Drug Quality |
Case Studies: Continuous Manufacturing of Drug Substance (21/33) Quality |
Conference/Workshop |
10/16/2019 |
Drug Quality |
Change Management: ICH Q12 and Established Conditions (12/33) Quality |
Conference/Workshop |
10/16/2019 |
Drug Quality |
Continuous Manufacturing of Drug Product (20/33) Quality |
Conference/Workshop |
10/16/2019 |
Drug Quality |
Data Quality Expectations for Biosimilars with Case Studies (29/33) Quality |
Conference/Workshop |
10/16/2019 |
Drug Quality |
Emerging Technology Program (18/33) Quality |
Conference/Workshop |
10/16/2019 |
Drug Quality |
End-to-end Integrated Continuous Manufacturing (25/33) Quality |
Conference/Workshop |
10/16/2019 |
Drug Quality |
FDA Perspectives on Biosimilar BLA-Manufacturing (28/33) Quality |
Conference/Workshop |
10/16/2019 |
Drug Quality |
FDA Research Supporting Emerging Technologies with Case Studies (24/33) Quality |
Conference/Workshop |
10/16/2019 |
Drug Quality |
FDA’s Quality Assessment and Knowledge Management - KASA (11/33) Quality |
Conference/Workshop |
10/16/2019 |
Drug Quality |
How Does FDA Execute Pre- and Post-approval Inspections? (7/33) Quality |
Conference/Workshop |
10/16/2019 |
Drug Quality |
Integration of Assessment and Inspection for Biological Products (9/33) Quality |
Conference/Workshop |
10/16/2019 |
Drug Quality |
Keynote: CDER’s Commitment to Pharmaceutical Quality (1/33) Quality |
Conference/Workshop |
10/16/2019 |
Drug Quality |
Panel Questions and Discussion (10/33) Quality |
Conference/Workshop |
10/16/2019 |
Drug Quality |
Panel Questions and Discussion (13/33) Quality |
Conference/Workshop |
10/16/2019 |
Drug Quality |
Panel Questions and Discussion (17/33) Quality |
Conference/Workshop |
10/16/2019 |
Drug Quality |
Panel Questions and Discussion (22/33) Quality |
Conference/Workshop |
10/16/2019 |
Drug Quality |
Panel Questions and Discussion (26/33) Quality |
Conference/Workshop |
10/16/2019 |
Drug Quality |
Panel Questions and Discussion (30/33) Quality |
Conference/Workshop |
10/16/2019 |
Drug Quality |
Panel Questions and Discussion (33/33) Quality |
Conference/Workshop |
10/16/2019 |
Drug Quality |
Panel Questions and Discussion (6/33) Quality |
Conference/Workshop |
10/16/2019 |
Drug Quality |
Pharmaceutical Quality Surveillance Program (14/33) Quality |
Conference/Workshop |
10/16/2019 |
Drug Quality |
Pharmaceutical Quality Symposium |
Conference/Workshop |
10/16/2019 |
Drug Quality |
Policy Considerations for Continuous Manufacturing (19/33) Quality |
Conference/Workshop |
10/16/2019 |
Drug Quality |
Policy Initiatives for Pharmaceutical Quality (5/33) Quality |
Conference/Workshop |
10/16/2019 |
Drug Quality |
Quality Assessment of BLAs, NDAs, and ANDAs (3/33) Quality |
Conference/Workshop |
10/16/2019 |
Drug Quality |
Quality Considerations for Transition Biological Products (32/33) Quality |
Conference/Workshop |
10/16/2019 |
Drug Quality |
Quality Metrics, Quality Culture, and Data-Driven Decisions (16/33) Quality |
Conference/Workshop |
10/16/2019 |
Drug Quality |
Quality-Related Compliance Actions and Trends (15/33) Quality |
Conference/Workshop |
10/16/2019 |
Drug Quality |
Small Molecule Case Studies (8/33) Quality |
Conference/Workshop |
10/16/2019 |
Drug Quality |
The “Deemed to be a License” Provision of the BPCI Act (31/33) Quality |
Conference/Workshop |
10/16/2019 |
Drug Quality; Biosimilars; BLA; NDA |
The Importance of Quality in Our Medicines (2/33) Quality |
Conference/Workshop |
10/16/2019 |
Drug Quality |
Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting System (FAERS) using International Council for Harmonisation (ICH) E2B(R3) Standards |
Webinar |
10/11/2019 |
Regulatory Submissions; Safety |
2019 Complex Generic Drug Product Development Workshop |
Conference/Workshop |
9/25/2019 |
Generic Drug Development; Drug Quality |
BE Approaches for Long Acting Drug Products (14/35) Complex Generics |
Conference/Workshop |
9/25/2019 |
Generic Drug Development; Drug Quality |
BE for Bridging Studies with Orally Inhaled/Nasal Drugs (26/35) Complex Generics |
Conference/Workshop |
9/25/2019 |
Generic Drug Development; Drug Quality |
Bioequivalence for Generic Topical and Transdermal (6/35) Complex Generics |
Conference/Workshop |
9/25/2019 |
Generic Drug Development; Drug Quality |
CMC Updates for Orally Inhaled Drugs (27/35) Complex Generics |
Conference/Workshop |
9/25/2019 |
Generic Drug Development; Drug Quality |
Comparative Analyses: Device and User Interface (25/35) Complex Generics |
Conference/Workshop |
9/25/2019 |
Generic Drug Development; Drug Quality |
Comparative Analyses: Injectable Combination Products (21/35) Complex Generics |
Conference/Workshop |
9/25/2019 |
Generic Drug Development; Drug Quality |
Complex Peptide ANDAs: Test/Reference Comparability (11/35) Complex Generics |
Conference/Workshop |
9/25/2019 |
Generic Drug Development; Drug Quality |
Considerations of Particle Analysis (12/35) Complex Generics |
Conference/Workshop |
9/25/2019 |
Generic Drug Development; Drug Quality |
CREdIbility for Computational Fluid Dynamics Models (33/35) Complex Generics |
Conference/Workshop |
9/25/2019 |
Generic Drug Development; Drug Quality |
Dose-Scale Analysis in Pharmacodynamic Equivalence (31/35) Complex Generics |
Conference/Workshop |
9/25/2019 |
Generic Drug Development; Drug Quality |
FDA’s Inactive IngREdIent Database (IID) (3/f35) Complex Generics |
Conference/Workshop |
9/25/2019 |
Generic Drug Development; Drug Quality |
Generic Topical and Transdermal Products (5/35) Complex Generics |
Conference/Workshop |
9/25/2019 |
Generic Drug Development; Drug Quality |
In Vitro Drug Release Testing for LA Drug Products QC (16/35) Complex Generics |
Conference/Workshop |
9/25/2019 |
Generic Drug Development; Drug Quality |
Keynote with Sally Choe (1/35) Complex Generics |
Conference/Workshop |
9/25/2019 |
Generic Drug Development; Drug Quality |
Overview of Comparative Analyses - Clinical Perspective (19/35) Complex Generics |
Conference/Workshop |
9/25/2019 |
Generic Drug Development; Drug Quality |
Panel Questions and Discussion (35/35) Complex Generics |
Conference/Workshop |
9/25/2019 |
Generic Drug Development; Drug Quality |
Physiologically-based Pharmacokinetic Modeling (32/35) Complex Generics |
Conference/Workshop |
9/25/2019 |
Generic Drug Development; Drug Quality |
PK/PD Meta-analysis of Abuse Deterrent Opioid Drugs (30/35) Complex Generics |
Conference/Workshop |
9/25/2019 |
Generic Drug Development; Drug Quality |
Pre-ANDA Meeting Requests for Orally Inhaled/Nasal Drugs(24/35) Complex Generics |
Conference/Workshop |
9/25/2019 |
Generic Drug Development; Drug Quality |
Pre-ANDA Program Update (2/35) Complex Generics |
Conference/Workshop |
9/25/2019 |
Generic Drug Development; Drug Quality |
PSG Recommendations and Updates for OINDPs (23/35) Complex Generics |
Conference/Workshop |
9/25/2019 |
Generic Drug Development; Drug Quality |
Quality for Transdermal Delivery Systems (8/35) Complex Generic Drugs |
Conference/Workshop |
9/25/2019 |
Generic Drug Development; Drug Quality |
Quality View on Injectable Product Considerations (20/35) Complex Generic Drugs |
Conference/Workshop |
9/25/2019 |
Generic Drug Development; Drug Quality |
Quantitative Clinical Pharmacology in LA Injectables (34/35) Complex Generics |
Conference/Workshop |
9/25/2019 |
Generic Drug Development; Drug Quality |
Quantitative Methods and Modeling (29/35) Complex Generics |
Conference/Workshop |
9/25/2019 |
Generic Drug Development; Drug Quality |
Questions and Answers (13/35) Complex Generics |
Conference/Workshop |
9/25/2019 |
Generic Drug Development; Drug Quality |
Questions and Answers (17/35) Complex Generics |
Conference/Workshop |
9/25/2019 |
Generic Drug Development; Drug Quality |
Questions and Answers (22/35) Complex Generics |
Conference/Workshop |
9/25/2019 |
Generic Drug Development; Drug Quality |
Questions and Answers (28/35) Complex Generics |
Conference/Workshop |
9/25/2019 |
Generic Drug Development; Drug Quality |
Questions and Answers (4/35) Complex Generics |
Conference/Workshop |
9/25/2019 |
Generic Drug Development; Drug Quality |
Questions and Answers (9/35) Complex Generic Drugs |
Conference/Workshop |
9/25/2019 |
Generic Drug Development; Drug Quality |
Strategies for Generic Topical Product Development (7/35) Complex Generics |
Conference/Workshop |
9/25/2019 |
Generic Drug Development; Drug Quality |
Strategies to Demonstrate Complex API Sameness (10/35) Complex Generics |
Conference/Workshop |
9/25/2019 |
Generic Drug Development; Drug Quality |
Strategies to Demonstrate Complex Excipient Sameness (15/35) Complex Generics |
Conference/Workshop |
9/25/2019 |
Generic Drug Development; Drug Quality |
What Constitutes Complex Drug-Device Combination (18/35) Complex Generics |
Conference/Workshop |
9/25/2019 |
Generic Drug Development; Drug Quality |
REdI and CERSI Workshop: Current State and Future Expectations of Translational Modeling Strategies to Support Drug Product Development, Manufacturing Changes and Controls |
Conference/Workshop |
9/23/2019 |
New Drug Development |
Abbreviated Approval Pathways - 505(b)(2) or ANDA? |
SBIA Chronicles |
9/19/2019 |
Generic Drug Development; NDA |
Abbreviated Approval Pathways - 505(b)(2) or ANDA? |
SBIA Chronicles Podcast |
9/19/2019 |
Generic Drug Development; NDA |
Most Common Issues with CDISC-SEND Data in FDA Toxicology Review |
Webinar |
9/12/2019 |
Regulatory Submissions |
eCTD Submissions of Promotional Labeling and Advertising Materials |
Webinar |
8/12/2019 |
Regulatory Submissions; Marketing |
Risk-Based Approach to Monitoring Clinical Investigations: Overview of FDA Draft Guidance Issued for Comment |
Webinar |
6/26/2019 |
Clinical Trials and Research |
Research Investigational New Drug Applications – What You Need To Know |
SBIA Chronicles |
6/25/2019 |
Clinical Trials and Research; IND |
Research Investigational New Drug Applications – What You Need To Know |
SBIA Chronicles Podcast |
6/25/2019 |
Clinical Trials and Research; IND |
Bioanalytical Method Validation of ANDAs – What the Assessor Looks for During Inspections |
Webinar |
6/17/2019 |
Generic Drug Development |
Accuracy and Precision in Bioanalysis: Review of Case Studies |
Webinar |
6/17/2019 |
New Drug Development |
Bioanalytical Method Validation (BMV) Panel Discussion |
Webinar |
6/17/2019 |
New Drug Development |
Bioanalytical Inspections: Overview and Case Studies |
Webinar |
6/17/2019 |
New Drug Development |
How should I measure this? An FDA perspective on the Bioanalytical Method Validation (BMV) |
Webinar |
6/17/2019 |
New Drug Development |
The Finalized Bioanalytical Method Validation Guidance: What’s New For NDAs and BLAs |
Webinar |
6/17/2019 |
New Drug Development; NDA; BLA |
Identification of Medicinal Products (IDMP): What is IDMP and Why Should I Care? |
Webinar |
6/13/2019 |
New Drug Development |
CDER FDA Exclusivity – Which One Is for Me? |
Webinar |
6/10/2019 |
User Fees; NDA; BLA |
FDA Orphan Drugs Program and Financial Incentives for CDER Medical Products |
Webinar |
6/10/2019 |
User Fees; NDA; BLA |
Financial Incentives for CDER Medical Products |
Webinar |
6/10/2019 |
User Fees; NDA; BLA |
Navigating the World of Biosimilar User Fees |
Webinar |
6/10/2019 |
BLA; User Fees |
Panel on Financial Incentives for CDER Medical Products - PDUFA & Biosimilars |
Webinar |
6/10/2019 |
User Fees; NDA; BLA |
Prescription Drug User Fee Act Waivers, Exemptions, and Refunds -Oh My |
Webinar |
6/10/2019 |
User Fees; NDA; BLA |
A Medical Officer’s Approach to NDA/BLA Review (8/15) REdI Annual Conference |
Conference/Workshop |
5/29/2019 |
New Drug Development; IND; Resources |
CDER Industry Assistance Resources (1/15) REdI |
Conference/Workshop |
5/29/2019 |
New Drug Development; IND; Resources |
CDER’s Review of the Prescribing Information (11/15) REdI– May 29-30, 2019 |
Conference/Workshop |
5/29/2019 |
New Drug Development; IND |
CMC - NDA requirements and Common Pitfalls of BLAs (14/15) REdI |
Conference/Workshop |
5/29/2019 |
New Drug Development; IND |
Components of New Drug Application and Biologics License Application (5/15) REdI |
Conference/Workshop |
5/29/2019 |
New Drug Development; IND |
Electronic Common Technical Document (eCTD) and Study Data (7/15) REdI |
Conference/Workshop |
5/29/2019 |
New Drug Development; IND |
Meetings: Pre-submission and Special Programs (4/15) REdI Annual Conference |
Conference/Workshop |
5/29/2019 |
New Drug Development; IND |
Navigating the World of Combination Products (2/15) REdI |
Conference/Workshop |
5/29/2019 |
New Drug Development; IND |
NDA and BLA Application Review Process (6/15) REdI Annual Conference |
Conference/Workshop |
5/29/2019 |
New Drug Development; IND |
Nonproprietary Name Suffix and Safety for Product Design and Labels (10/15) REdI |
Conference/Workshop |
5/29/2019 |
New Drug Development; IND |
ORA Aligned for the Future (1/15) REdI |
Conference/Workshop |
5/29/2019 |
New Drug Development; IND |
Pre-Approval Inspections: What to Expect When Being Inspected (15/15) REdI |
Conference/Workshop |
5/29/2019 |
New Drug Development; IND; Inspections |
Ready to Launch: Essentials of Submitting Initial Materials to OPDP (12/15) REdI |
Conference/Workshop |
5/29/2019 |
New Drug Development; IND; Marketing |
Regulatory Education for Industry (REdI) Annual Conference - Focus on Essentials of NDAs and BLAs |
Conference/Workshop |
5/29/2019 |
User Fees; NDA; BLA |
Regulatory Highlights for Biosimilars and Interchangeables (9/15) REdI |
Conference/Workshop |
5/29/2019 |
New Drug Development; IND |
What can CDER do for you? (3/15) REdI Annual Conference |
Conference/Workshop |
5/29/2019 |
New Drug Development; IND |
Competitive Generic Therapies |
SBIA Chronicles |
5/23/2019 |
Generic Drug Development |
Competitive Generic Therapies |
SBIA Chronicles Podcast |
5/23/2019 |
Generic Drug Development |
Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics: Overview of FDA Draft Guidance Issued for Comment |
Webinar |
5/13/2019 |
New Drug Development; Real World Evidence |
An Introduction to FDA MyStudies: An Open-Source, Digital Platform to Gather Real World Data for Clinical Trials and Research Studies |
Webinar |
5/9/2019 |
Clinical Trials and Research |
Deploying the MyStudies System in a Compliant Manner (8/9) MyStudies App |
Webinar |
5/9/2019 |
New Drug Development; Real World Evidence |
Final Question and Answer Panel (9/9) MyStudies App |
Webinar |
5/9/2019 |
New Drug Development; Real World Evidence |
Introduction (1/9) FDA MyStudies Mobile App System |
Webinar |
5/9/2019 |
New Drug Development; Real World Evidence |
Mobile Application and WCP: Usability and Technical Overview (5/9) FDA MyStudies App |
Webinar |
5/9/2019 |
New Drug Development; Real World Evidence |
Patient and Researcher Experiences: A Demonstration (2/9) FDA MyStudies App |
Webinar |
5/9/2019 |
New Drug Development; Real World Evidence |
Patient and Researcher Experiences: Demo of the FDA MyStudies Mobile App (3/9) |
Webinar |
5/9/2019 |
New Drug Development; Real World Evidence |
Question and Answer Panel (7/9) MyStudies App |
Webinar |
5/9/2019 |
New Drug Development; Real World Evidence |
Question and Answer Session Martin and Wyner (4/9) FDA MyStudies App |
Webinar |
5/9/2019 |
New Drug Development; Real World Evidence |
Response Server Technical Overview (6/9) FDA MyStudies App |
Webinar |
5/9/2019 |
New Drug Development; Real World Evidence |
505(b)(2) NDA or ANDA? (10/28) Generic Drug Forum |
Conference/Workshop |
4/3/2019 |
Generic Drug Development; Drug Quality |
Assessment Tips (17/28) Generic Drug Forum |
Conference/Workshop |
4/3/2019 |
Generic Drug Development; Drug Quality |
Case Studies: Inadequate Bioequivalence Studies (18/28) Generic Drug Forum |
Conference/Workshop |
4/3/2019 |
Generic Drug Development; Drug Quality |
Complex Product Development (3/28) Generic Drug Forum |
Conference/Workshop |
4/3/2019 |
Generic Drug Development; Drug Quality |
Continuous Manufacturing with a Generic Perspective (25/28) Generic Drug Forum |
Conference/Workshop |
4/3/2019 |
Generic Drug Development; Drug Quality |
Decrease RTR, IR, and CR Due to Dissolution Deficiencies (21/28) Generic Drug Forum |
Conference/Workshop |
4/3/2019 |
Generic Drug Development; Drug Quality |
Deficiencies and Observations from Facility Evaluations and Inspections(27/28) Generic Drug Forum |
Conference/Workshop |
4/3/2019 |
Generic Drug Development; Drug Quality |
Drug Master Files (DMFs) from an ANDA Perspective (7/28) Generic Drug Forum |
Conference/Workshop |
4/3/2019 |
Generic Drug Development; Drug Quality |
Filing and Refuse to Receive (RTR) (16/28) Generic Drug Forum |
Conference/Workshop |
4/3/2019 |
Generic Drug Development; Drug Quality |
Generic Drug Forum: April 3-4, 2019 |
Conference/Workshop |
4/3/2019 |
Generic Drug Development; Drug Quality |
Impurity Case Studies: Pharmacology/Toxicology (22/28) Generic Drug Forum |
Conference/Workshop |
4/3/2019 |
Generic Drug Development; Drug Quality |
Keynote: Generic Drug Program Update (1/28) Generic Drug Forum |
Conference/Workshop |
4/3/2019 |
Generic Drug Development; Drug Quality |
Manufacturing Process and Controls: Avoiding Assessment Issues (26/28) Generic Drug Forum |
Conference/Workshop |
4/3/2019 |
Generic Drug Development; Drug Quality |
Mid-cycle Assessment and Post-complete Response Letter Meetings (6/28) Generic Drug Forum |
Conference/Workshop |
4/3/2019 |
Generic Drug Development; Drug Quality |
Orange Book - Its Role in ANDAs (8/28) Generic Drug Forum |
Conference/Workshop |
4/3/2019 |
Generic Drug Development; Drug Quality |
Practical Tips on eCTD (13/28) Generic Drug Forum |
Conference/Workshop |
4/3/2019 |
Generic Drug Development; Drug Quality |
Pre-ANDA Meeting or Controlled Correspondence? (4/28) Generic Drug Forum |
Conference/Workshop |
4/3/2019 |
Generic Drug Development; Drug Quality |
Questions and Answers (11/28) Generic Drug Forum |
Conference/Workshop |
4/3/2019 |
Generic Drug Development; Drug Quality |
Questions and Answers (15/28) Generic Drug Forum |
Conference/Workshop |
4/3/2019 |
Generic Drug Development; Drug Quality |
Questions and Answers (19/28) Generic Drug Forum |
Conference/Workshop |
4/3/2019 |
Generic Drug Development; Drug Quality |
Questions and Answers (23/28) Generic Drug Forum |
Conference/Workshop |
4/3/2019 |
Generic Drug Development; Drug Quality |
Questions and Answers (28/28) Generic Drug Forum |
Conference/Workshop |
4/3/2019 |
Generic Drug Development; Drug Quality |
Questions and Answers (5/28) Generic Drug Forum |
Conference/Workshop |
4/3/2019 |
Generic Drug Development; Drug Quality |
Referencing Approved Drug Products in ANDA Submissions (9/28) Generic Drug Forum |
Conference/Workshop |
4/3/2019 |
Generic Drug Development; Drug Quality |
Stability Case Studies (20/28) Generic Drug Forum |
Conference/Workshop |
4/3/2019 |
Generic Drug Development; Drug Quality |
The Importance of Quality in Our Medicines (2/28) Generic Drug Forum |
Conference/Workshop |
4/3/2019 |
Generic Drug Development; Drug Quality |
Tips on Using the CDER NextGen Collaboration Portal (12/28) Generic Drug Forum |
Conference/Workshop |
4/3/2019 |
Generic Drug Development; Drug Quality |
Types of Fees and Q&A (24/28) Generic Drug Forum |
Conference/Workshop |
4/3/2019 |
Generic Drug Development; Drug Quality |
Update on Technical Rejection Criteria for Study Data (14/28) Generic Drug Forum |
Conference/Workshop |
4/3/2019 |
Generic Drug Development; Drug Quality |
A New Era for Homeopathic Drug Product Regulation |
SBIA Chronicles Podcast |
3/22/2019 |
New Drug Development |
Framework for FDA’s Real-World Evidence Program |
Webinar |
3/15/2019 |
New Drug Development; Real World Evidence |
Human Drug Establishment Registration and Drug Listing Compliance; CDERLearn Course Certificates of completion and embedded videos are no longer available. |
CDERLearn Course |
3/12/2019 |
Registration and Listing |
FDA Modernizes Clinical Trials with Master Protocols |
SBIA Chronicles |
2/26/2019 |
New Drug Development; IND; Clinical Trials and Research |
FDA Modernizes Clinical Trials with Master Protocols |
SBIA Chronicles Podcast |
2/26/2019 |
New Drug Development; IND; Clinical Trials and Research |
Final Guidance for Industry: Use of Electronic Health Record Data in Clinical Investigations |
Webinar |
12/6/2018 |
Clinical Trials and Research; Regulatory Submissions |
Early Engagement with FDA to Discuss Novel Surrogate Endpoints |
SBIA Chronicles |
11/27/2018 |
New Drug Development; FDA Meetings/Communications |
Early Engagement with FDA to Discuss Novel Surrogate Endpoints |
SBIA Chronicles Podcast |
11/27/2018 |
New Drug Development; FDA Meetings/Communications |
FDA Study Data Technical Conformance Guide |
Webinar |
11/27/2018 |
Regulatory Submissions |
Clinical Investigator Training Course (CITC) 2018: November 13 - 15, 2018 |
Conference/Workshop |
11/13/2018 |
New Drug Development; Clinical Trials |
FDA Facilitates the Use of Surrogate Endpoints in Drug Development |
SBIA Chronicles |
11/5/2018 |
Clinical Trials and Research; IND |
FDA Facilitates the Use of Surrogate Endpoints in Drug Development |
SBIA Chronicles Podcast |
11/5/2018 |
Clinical Trials and Research; IND |
A Case Example of the Review of Audit Trails in GCP Inspections (11/11) GCP Data Integrity Workshop |
Conference/Workshop |
10/23/2018 |
Clinical Trials and Research |
Blinding of Bioequivalence Trials (9/11) GCP Data Integrity |
Conference/Workshop |
10/23/2018 |
Clinical Trials and Research |
Data Integrity from International Perspectives (2/11) GCP Data Integrity Workshop |
Conference/Workshop |
10/23/2018 |
Clinical Trials and Research |
Data Quality: Why Do We Care? (1/11) GCP Data Integrity |
Conference/Workshop |
10/23/2018 |
Clinical Trials and Research |
Effective Use of Audit Trails (10/11) GCP Data Integrity Workshop |
Conference/Workshop |
10/23/2018 |
Clinical Trials and Research |
FDA & MHRA Good Clinical Practice Workshop: Data Integrity in Global Clinical Trials - Are We There Yet?: October 23-24, 2018 |
Conference/Workshop |
10/23/2018 |
New Drug Development; Clinical Trials and Research |
Good Clinical Practice Assessment of Data Reliability in Registration Trials (5/11) GCP Data |
Conference/Workshop |
10/23/2018 |
Clinical Trials and Research |
Overview of Data Integrity (4/11) GCP Data Integrity Workshop |
Conference/Workshop |
10/23/2018 |
Clinical Trials and Research |
Quality and Control of Clinical Trial Data (6/11) GCP Data Integrity Workshop |
Conference/Workshop |
10/23/2018 |
Clinical Trials and Research |
Quality Management Systems and Quality By Design (3/11) GCP Data Integrity Workshop |
Conference/Workshop |
10/23/2018 |
Clinical Trials and Research |
The Data Management Plan – Pulling It All Together (7/11) GCP Data Integrity Workshop |
Conference/Workshop |
10/23/2018 |
Clinical Trials and Research |
Unblinding – Let Me Count the Ways… (8/11) GCP Data Integrity |
Conference/Workshop |
10/23/2018 |
Clinical Trials and Research |
Electronic Drug Registration and Listing Using CDER Direct: October 2, 2018 |
Conference/Workshop |
10/2/2018 |
Registration and Listing |
Writing the “Indications and Usage” Section of Labeling: FDA’s New Draft Guidance |
Webinar |
9/27/2018 |
Labeling |
Real-Time Review of Drug Applications is Now a Reality |
SBIA Chronicles |
9/20/2018 |
IND; NDA |
Real-Time Review of Drug Applications is Now a Reality |
SBIA Chronicles Podcast |
9/20/2018 |
IND; NDA |
Complex Generic Drug Product Development Workshop |
Conference/Workshop |
9/12/2018 |
Generic Drug Development; Drug Quality |
Common Issues in Complex Drug Substance Review (8of39) Complex Generics 2018 |
Conference/Workshop |
9/12/2018 |
Generic Drug Development; Drug Quality |
Considerations for Establishing Q1/Q2 Sameness of Complex Formulations (10/39) Complex Generics '18 |
Conference/Workshop |
9/12/2018 |
Generic Drug Development; Drug Quality |
Considerations in Demonstrating Complex API Sameness (7/39) Complex Generics 2018 |
Conference/Workshop |
9/12/2018 |
Generic Drug Development; Drug Quality |
Equivalence testing of complex particle size distribution profiles-earth mover’s distance (15/39) |
Conference/Workshop |
9/12/2018 |
Generic Drug Development; Drug Quality |
Establishing Appropriate BE Limits for Complex Formulations (14/39) Complex Generics 2018 |
Conference/Workshop |
9/12/2018 |
Generic Drug Development; Drug Quality |
In vitro bioequivalence testing for topical ophthalmic suspension products (17/39) Complex Generics |
Conference/Workshop |
9/12/2018 |
Generic Drug Development; Drug Quality |
In Vitro Release Testing of Complex Formulations (11/39) Complex Generics 2018 |
Conference/Workshop |
9/12/2018 |
Generic Drug Development; Drug Quality |
Iron Colloid Drug Products: Characterization and Impurity (13/39) Complex Generics 2018 |
Conference/Workshop |
9/12/2018 |
Generic Drug Development; Drug Quality |
Multivesicular Liposomes: Physicochemical characterization & in vitro drug release testing (12/39) |
Conference/Workshop |
9/12/2018 |
Generic Drug Development; Drug Quality |
Office of Generic Drugs Keynote (1/39) Complex Generics 2018 |
Conference/Workshop |
9/12/2018 |
Generic Drug Development; Drug Quality |
PBPK modeling and simulation used in assessing BE for generic ophthalmic products (19/39) |
Conference/Workshop |
9/12/2018 |
Generic Drug Development; Drug Quality |
Peptide Drug Challenges through Pre-ANDA Processes & Case Studies (6/39) Complex Generics 2018 |
Conference/Workshop |
9/12/2018 |
Generic Drug Development; Drug Quality |
Pre-ANDA Logistics and Best Practices (3/39) Complex Generics 2018 |
Conference/Workshop |
9/12/2018 |
Generic Drug Development; Drug Quality |
Pre-ANDA Program Overview (2/39) Complex Generics 2018 |
Conference/Workshop |
9/12/2018 |
Generic Drug Development; Drug Quality |
Pre-ANDA review: Office of Pharmaceutical Quality (OPQ) (4/39) Complex Generics 2018 |
Conference/Workshop |
9/12/2018 |
Generic Drug Development; Drug Quality |
Product Quality Testing for Topical Ophthalmic Suspension Products (18/39) Complex Generics 2018 |
Conference/Workshop |
9/12/2018 |
Generic Drug Development; Drug Quality |
Questions and Panel Discussion (16/39) Complex Generics 2018 |
Conference/Workshop |
9/12/2018 |
Generic Drug Development; Drug Quality |
Questions and Panel Discussion (20/39) Complex Generics 2018 |
Conference/Workshop |
9/12/2018 |
Generic Drug Development; Drug Quality |
Questions and Panel Discussion (5/39) Complex Generics 2018 |
Conference/Workshop |
9/12/2018 |
Generic Drug Development; Drug Quality |
Questions and Panel Discussion (9/39) Complex Generics 2018 |
Conference/Workshop |
9/12/2018 |
Generic Drug Development; Drug Quality |
Complex Generic Drug Product Development Workshop - September 12-13, 2018 |
Conference/Workshop |
9/12/2018 |
Generic Drug Development; Drug Quality |
The FAERS Public Dashboard and its Value to the Pharmaceutical Industry |
SBIA Chronicles |
7/10/2018 |
Safety |
The FAERS Public Dashboard and its Value to the Pharmaceutical Industry |
SBIA Chronicles Podcast |
7/10/2018 |
Safety |
Postmarketing Drug Safety and Inspection Readiness - June 19, 2018 Deeper Dive Webinar |
Webinar |
6/19/2018 |
Inspections; Safety; Postapproval |
BIMO, REMS, and PADE Inspection Readiness (3/3) |
Webinar |
6/19/2018 |
Safety; Inspections; Postapproval |
Postmarketing Adverse Drug Experience (PADE) Inspections – (1/3) |
Webinar |
6/19/2018 |
Safety; Inspections; Postapproval |
Risk Evaluation and Mitigation Strategies (REMS) Inspections (2/3) |
Webinar |
6/19/2018 |
Safety; Inspections; Postapproval |
Benefit-Risk Considerations During Drug Product Development (8/14) REdI 2018 |
Conference/Workshop |
5/18/2018 |
Drug Development; IND; NDA |
CDER Small Business and Industry Assistance Overview (12/14) REdI 2018 |
Conference/Workshop |
5/18/2018 |
Drug Development; IND; NDA; Resources |
Chemistry, Manufacturing, and Controls (CMC) for an IND (7/14) REdI 2018 |
Conference/Workshop |
5/18/2018 |
Drug Development; IND; NDA |
Demystifying the Investigational New Drug (IND) Application for Drugs and Biologics (3/14) REdI 2018 |
Conference/Workshop |
5/18/2018 |
Drug Development; IND; NDA |
FDA Regulatory Requirements for Clinical Investigators and Case Examples (9/14) REdI 2018 |
Conference/Workshop |
5/18/2018 |
Drug Development; IND; NDA |
Formal Meetings for PDUFA Products and Communication Best Practices (4/14) REdI 2018 |
Conference/Workshop |
5/18/2018 |
Drug Development; IND; NDA |
Good Manufacturing Practices (GMPs) from an IND Perspective (11/14) REdI 2018 |
Conference/Workshop |
5/18/2018 |
Drug Development; IND; NDA |
Human Factors Engineering in Medical Products Reviews (2/14) REdI 2018 |
Conference/Workshop |
5/18/2018 |
Drug Development; IND; NDA |
Investigational New Drug (IND) Submission: Content/Format and First 30 Days (5/14) REdI 2018 |
Conference/Workshop |
5/18/2018 |
Drug Development; IND; NDA |
Investigational New Drug Safety Reporting Requirements (10/14) REdI 2018 |
Conference/Workshop |
5/18/2018 |
Drug Development; IND; NDA |
Nonclinical Safety Assessment for Small Molecules and Biologic Drug Development (6/14) REdI 2018 |
Conference/Workshop |
5/18/2018 |
Drug Development; IND; NDA |
Office of Regulatory Affairs Update (1/14) REdI 2018 |
Conference/Workshop |
5/18/2018 |
Drug Development; IND; NDA |
Panel Discussion (27/27) Generic Drugs Forum April 11-12, 2018 |
Conference/Workshop |
5/18/2018 |
Drug Development; IND; NDA |
The Active IND and Available Development Programs (13/14) REdI 2018 |
Conference/Workshop |
5/18/2018 |
Drug Development; IND; NDA |
Walkthrough of a Pre-Approval Manufacturing Site Inspection (14/14) REdI 2018 |
Conference/Workshop |
5/18/2018 |
Drug Development; IND; NDA |
Regulatory Education for Industry (REdI) Spring Conference: May 15-16, 2018 |
Conference/Workshop |
5/15/2018 |
New Drug Development; IND |
Optimizing Your Data Submissions to FDA: Office of Vaccines Research and Review (OVRR) Data Submission |
Webinar |
5/8/2018 |
Regulatory Submissions |
Updates to Forms 356h & 1571: Commercial vs. Research Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT) Combination Products |
Webinar |
5/4/2018 |
Regulatory Submissions |
ANDA Performance/Operations Update (3/27) Generic Drugs Forum April 2018 |
Conference/Workshop |
4/11/2018 |
Generic Drug Development; Drug Quality |
Application Communications: RBPM Communication with Industry throughout the IQA (24/27) Generic Drugs Forum 2018 |
Conference/Workshop |
4/11/2018 |
Generic Drug Development; Drug Quality |
Best Practices for Conducting Bioequivalence Studies (16/27) Generic Drugs Forum 2018 |
Conference/Workshop |
4/11/2018 |
Generic Drug Development; Drug Quality |
Bioequivalence Site and Manufacturing Facility Information in Applications (17/27) Generic Drugs Forum 2018 |
Conference/Workshop |
4/11/2018 |
Generic Drug Development; Drug Quality |
Challenges in Generic Drug Safety and Surveillance (6/27) Generic Drugs Forum 2018 |
Conference/Workshop |
4/11/2018 |
Generic Drug Development; Drug Quality |
Determining Whether to Submit an ANDA or a 505(b)(2) Application (12/27) Generic Drugs Forum 2018 |
Conference/Workshop |
4/11/2018 |
Generic Drug Development; Drug Quality |
Drug Substance Quality Assessment: Best Practices (23/27) Generic Drugs Forum 2018 |
Conference/Workshop |
4/11/2018 |
Generic Drug Development; Drug Quality |
Electronic Submissions (7/27) Generic Drugs Forum 2018 |
Conference/Workshop |
4/11/2018 |
Generic Drug Development; Regulatory Submissions |
Filing Review Basics – Examples of Refuse-to-Receive (RTR) (15/27) Generic Drugs Forum 2018 |
Conference/Workshop |
4/11/2018 |
Generic Drug Development; Drug Quality |
GDUFA II – Review Timelines (14/27) Generic Drugs Forum 2018 |
Conference/Workshop |
4/11/2018 |
Generic Drug Development; Drug Quality |
GDUFA II Pre-ANDA Program Meetings: Advice for Success (10/27) Generic Drugs Forum 2018 |
Conference/Workshop |
4/11/2018 |
Generic Drug Development; Drug Quality; FDA Meetings/Communications |
GDUFA II User Fees: Update on Year One (21/27) Generic Drugs Forum 2018 |
Conference/Workshop |
4/11/2018 |
Generic Drug Development; Drug Quality |
Generic Drug Product Quality Assessment (22/27) Generic Drugs Forum 2018 |
Conference/Workshop |
4/11/2018 |
Generic Drug Development; Drug Quality |
Generic Drugs Forum: April 11 -12, 2018 |
Conference/Workshop |
4/11/2018 |
Generic Drug Development |
Good ANDA Submission and Assessment Practices and Software Support (5/27) Generic Drugs Forum 2018 |
Conference/Workshop |
4/11/2018 |
Generic Drug Development; Drug Quality |
Integrated Process and Facilities Assessment (26/27) Generic Drugs Forum 2018 |
Conference/Workshop |
4/11/2018 |
Generic Drug Development; Drug Quality |
Integrated Quality Assessment Process (19/27) Generic Drugs Forum 2018 |
Conference/Workshop |
4/11/2018 |
Generic Drug Development; Drug Quality |
Keynote Address by Dr. Uhl (1/27) Generic Drugs Forum 2018 |
Conference/Workshop |
4/11/2018 |
Generic Drug Development; Drug Quality |
Laboratory Science to Support Risk-Based Quality Assessments (25/27) Generic Drugs Forum 2018 |
Conference/Workshop |
4/11/2018 |
Generic Drug Development; Drug Quality |
Microbiology Quality Assessment (18/27) Generic Drugs Forum 2018 |
Conference/Workshop |
4/11/2018 |
Generic Drug Development; Drug Quality |
Office of Pharmaceutical Quality (OPQ) Policy Update (4/27) Generic Drugs Forum April 2018 |
Conference/Workshop |
4/11/2018 |
Generic Drug Development; Drug Quality |
Orange Book: 101 An Overview (11/27) Generic Drugs Forum 2018 |
Conference/Workshop |
4/11/2018 |
Generic Drug Development; Drug Quality |
Panel Discussion (13/27) Generic Drugs Forum 2018 |
Conference/Workshop |
4/11/2018 |
Generic Drug Development; Drug Quality |
Panel Discussion (20/27) Generic Drugs Forum 2018 |
Conference/Workshop |
4/11/2018 |
Generic Drug Development; Drug Quality |
Panel Discussion (9/27) Generic Drugs Forum 2018 |
Conference/Workshop |
4/11/2018 |
Generic Drug Development; Drug Quality |
Pharmaceutical Quality Update by Dr. Michael Kopcha (2/27) Generic Drugs Forum April 2018 |
Conference/Workshop |
4/11/2018 |
Generic Drug Development; Drug Quality |
Using the ePortal to Submit a pre-ANDA Meeting (8/27) Generic Drugs Forum 2018 |
Conference/Workshop |
4/11/2018 |
Generic Drug Development; Drug Quality |
A New Era for Homeopathic Drug Product Regulation |
SBIA Chronicles |
3/22/2018 |
New Drug Development |
A New Era for Homeopathic Drug Product Regulation |
SBIA Chronicles Podcast |
3/22/2018 |
New Drug Development |
FDA Helping the Generic Industry Submit Complete Applications |
SBIA Chronicles |
2/6/2018 |
Generic Drug Development; Regulatory Submissions |
FDA Helping the Generic Industry Submit Complete Applications |
SBIA Chronicles Podcast |
2/6/2018 |
Generic Drug Development; Regulatory Submissions |
Draft guidance for Industry: Information Requests and Discipline Review Letters Under GDUFA |
Webinar |
12/18/2017 |
Generic Drug Development; Regulatory Submissions |
REMS Integration Initiative: An Overview |
Webinar |
12/4/2017 |
Safety |
PDUFA VI - A Time for Change |
SBIA Chronicles |
11/28/2017 |
User Fees; NDA |
PDUFA VI - A Time for Change |
SBIA Chronicles Podcast |
11/28/2017 |
User Fees; NDA |
Optimizing Your Study Data Submissions to FDA –Study Data Technical Conformance Guide October 2017 Version Update |
Webinar |
11/8/2017 |
Regulatory Submissions |
Prescription Drug Labeling Conference 2017 |
Conference/Workshop |
11/2/2017 |
Labeling |
Draft Guidance for Industry: Controlled Correspondence Related to Generic Drug Development |
Webinar |
11/2/2017 |
Generic Drug Development |
PLR Implementation, CDER Staff for Labeling Review, and Resources (1/9) Prescription Drug Labeling 2017 |
Conference/Workshop |
11/2/2017 |
Labeling |
Consistency, Optimizing Communication, and Best Labeling Practices (2/9) Prescription Drug Labeling 2017 |
Conference/Workshop |
11/2/2017 |
Labeling |
Considerations for Developing the Indications and Usage Section of Labeling (3/9) Labeling 2017 |
Conference/Workshop |
11/2/2017 |
Labeling |
Converting Labeling for Older Drugs from the Old Format to the PLR Format (4/9) Prescription Drug Labeling 2017 |
Conference/Workshop |
11/2/2017 |
Labeling |
Novel and Adaptive Labeling Approaches: PLR and Beyond (5/9) Labeling 2017 |
Conference/Workshop |
11/2/2017 |
Labeling |
Cracking the Code for Clinical Pharmacology-Related Prescription Drug Labeling (6/9) Prescription Drug Labeling 2017 |
Conference/Workshop |
11/2/2017 |
Labeling |
Overview of SPL and Challenges with Medication Guide Extraction and Data Mining (7/9)Prescription Drug Labeling 2017 |
Conference/Workshop |
11/2/2017 |
Labeling |
Lessons Learned with the Pregnancy and Lactation Labeling Rule (PLLR) (8/9) Prescription Drug Labeling 2017 |
Conference/Workshop |
11/2/2017 |
Labeling |
Safety Considerations for Patient Instructions to Minimize Medication Errors (9/9) Labeling 2017 |
Conference/Workshop |
11/2/2017 |
Labeling |
Draft Guidance for Industry: Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA |
Webinar |
11/1/2017 |
Generic Drug Development; FDA Meetings/Communications |
Draft Guidance for Industry: Determining Whether to Submit an ANDA or 505(b)(2) Application |
Webinar |
10/13/2017 |
Generic Drug Development; NDA |
Electronic Drug Registration & Listing Using CDER Direct: Extended Webinar |
Webinar |
10/5/2017 |
Registration and Listing |
Draft Guidance for Industry: Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA |
Webinar |
10/2/2017 |
Generic Drug Development; FDA Meetings/Communications |
Regulatory Education for Industry (REdI): Fall Conference: September 27-28, 2017 |
Conference/Workshop |
9/27/2017 |
New Drug Development; IND |
Keynote (1/14) REdI 2017 |
Conference/Workshop |
9/27/2017 |
New Drug Development; IND |
Plenary: Regulatory Research at FDA (2/14) REdI 2017 |
Conference/Workshop |
9/27/2017 |
New Drug Development; IND |
Introduction to Investigational New Drug (IND) Applications (3/14) REdI 2017 |
Conference/Workshop |
9/27/2017 |
New Drug Development; IND |
FDA Communication During Drug Development (4/14) REdI 2017 |
Conference/Workshop |
9/27/2017 |
New Drug Development; IND; FDA Meetings/Communications |
Regulatory and Administrative Components of an IND Application (5/14) REdI 2017 |
Conference/Workshop |
9/27/2017 |
New Drug Development; IND; Regulatory Submissions |
Benefit-Risk Considerations in Drug Development (6/14) REdI 2017 |
Conference/Workshop |
9/27/2017 |
New Drug Development; IND |
Chemistry, Manufacturing Controls (CMC) in an Investigational New Drug (IND) (7/14) REdI 2017 |
Conference/Workshop |
9/27/2017 |
New Drug Development; IND; Drug Quality |
Overview of Non-clinical Assessment in Drug Development (8/14) REdI 2017 |
Conference/Workshop |
9/27/2017 |
New Drug Development; IND |
Submit Your Investigational New Drug (IND) Application and Clinical Holds (9/14) REdI 2017 |
Conference/Workshop |
9/27/2017 |
New Drug Development; IND; Regulatory Submissions |
Additional Sponsor Responsibilities (10/14) REdI 2017 |
Conference/Workshop |
9/27/2017 |
New Drug Development; IND |
Overview of Clinical Investigator Responsibilities and Inspectional Findings (11/14) REdI 2017 |
Conference/Workshop |
9/27/2017 |
New Drug Development; IND |
Walkthrough of an FDA Clinical Investigator Site Inspection (12/14) REdI 2017 |
Conference/Workshop |
9/27/2017 |
New Drug Development; IND; Inspections |
Overview of FDA's Expanded Access Program (13/14) REdI 2017 |
Conference/Workshop |
9/27/2017 |
New Drug Development; IND |
Live Demo of the FDA Adverse Events Reporting System (14/14) REdI 2017 |
Conference/Workshop |
9/27/2017 |
New Drug Development; IND; Drug Safety |
Real-World Data and Evidence in Drug Development |
SBIA Chronicles |
8/24/2017 |
New Drug Development |
Electronic Common Technical Document (eCTD): CDERLearn Course Certificates of completion and embedded videos are no longer available. |
CDERLearn Course |
8/3/2017 |
Regulatory Submissions |
Optimizing Your Study Data Submissions to FDA – Updates from CDER and CBER |
Webinar |
7/13/2017 |
Regulatory Submissions |
Updates to the Study Data Technical Conformance Guide (1/4) Technical Conformance |
Webinar |
7/13/2017 |
Regulatory Submissions |
Providing Clinical Study Data to the Office of Vaccines (2/4) Tech Conformance |
Webinar |
7/13/2017 |
Regulatory Submissions |
Biologics Quality Bioresearch and Study Data Submissions (3/4) Technical Conformance |
Webinar |
7/13/2017 |
Regulatory Submissions |
Panel Questions and Discussion (4/4) Study Data Technical Conformance Webinar |
Webinar |
7/13/2017 |
Regulatory Submissions |
Draft Guidance for Industry: ANDA Submissions – Amendments to Abbreviated New Drug Applications Under GDUFA II II |
Webinar |
7/5/2017 |
Generic Drug Development; Regulatory Submissions |
Presenting Clinical Pharmacology Information in Prescription Drug Labeling |
Webinar |
6/19/2017 |
Labeling |
Risk Evaluation and Mitigation Strategies (REMS): A Deeper Dive |
Webinar |
6/15/2017 |
New Drug Development; Safety |
REMS Purpose, Process, and Challenges (1/2) REMS Webinar |
Webinar |
6/15/2017 |
New Drug Development; Safety |
Structured Product Labeling Format: An Introduction (2/2) REMS Webinar |
Webinar |
6/15/2017 |
New Drug Development; Safety; Regulatory Submissions |
Submitting Master Files in eCTD Format: When and How to Comply |
SBIA Chronicles |
5/25/2017 |
Drug Master Files; Regulatory Submissions |
Submitting Master Files in eCTD Format: When and How to Comply |
SBIA Chronicles Podcast |
5/25/2017 |
Drug Master Files; Regulatory Submissions |
Regulatory Education for Industry (REdI): Spring Conference: May 9-10, 2017 |
Conference/Workshop |
5/9/2017 |
New Drug Development; IND |
The Complexities of Compounding |
SBIA Chronicles |
4/20/2017 |
Compounding |
The Complexities of Compounding |
SBIA Chronicles Podcast |
4/20/2017 |
Compounding |
Generic Drugs Forum: April 4-5, 2017 |
Conference/Workshop |
4/4/2017 |
Generic Drug Development |
Keynote – Office of Generic Drugs (1/28) Generic Drugs Forum 2017 |
Conference/Workshop |
4/4/2017 |
Generic Drug Development |
Keynote – Office of Pharmaceutical Quality (2/28) Generic Drugs Forum 2017 |
Conference/Workshop |
4/4/2017 |
Generic Drug Development; Drug Quality |
ANDA Performance/Operations Update (3/28) Generic Drugs Forum 2017 |
Conference/Workshop |
4/4/2017 |
Generic Drug Development |
Office of Pharmaceutical Quality Policy Update (4/28) Generic Drugs Forum 2017 |
Conference/Workshop |
4/4/2017 |
Generic Drug Development; Drug Quality |
GDUFA Regulatory Science Research Update (5/28) Generic Drugs Forum 2017 |
Conference/Workshop |
4/4/2017 |
Generic Drug Development |
Preparing for GDUFA II User Fees (6/28) Generic Drugs Forum 2017 |
Conference/Workshop |
4/4/2017 |
Generic Drug Development |
eCTD (7/28) Generic Drugs Forum 2017 |
Conference/Workshop |
4/4/2017 |
Generic Drug Development; Regulatory Submissions |
Panel Discussion (8/28) Generic Drugs Forum 2017 |
Conference/Workshop |
4/4/2017 |
Generic Drug Development; Regulatory Submissions; Drug Quality |
GDUFA II (9/28) Generic Drugs Forum 2017 |
Conference/Workshop |
4/4/2017 |
Generic Drug Development; User Fees |
Development of Single, Shared System REMS (10/28) Generic Drugs Forum 2017 |
Conference/Workshop |
4/4/2017 |
Generic Drug Development; Drug Safety |
Introduction to “The ANDA Review Pathway” (11/28) Generic Drugs Forum 2017 |
Conference/Workshop |
4/4/2017 |
Generic Drug Development |
ANDA Policy and Regulatory Considerations Prior to Filing (12/28) Generic Drugs Forum 2017 |
Conference/Workshop |
4/4/2017 |
Generic Drug Development |
Panel Discussion (13/28) Generic Drugs Forum 2017 |
Conference/Workshop |
4/4/2017 |
Generic Drug Development |
Filing Review – Do’s and Don’ts (14/28) Generic Drugs Forum 2017 |
Conference/Workshop |
4/4/2017 |
Generic Drug Development; Regulatory Submissions |
RPM Communications Associated with “Take Action” Process (15/28) Generic Drugs Forum 2017 |
Conference/Workshop |
4/4/2017 |
Generic Drug Development |
FDA’s Bioequivalence Recommendations for Generic Drugs (16/28) Generic Drugs Forum 2017 |
Conference/Workshop |
4/4/2017 |
Generic Drug Development |
Review of Clinical Endpoint Bioequivalence Studies in ANDAs (17/28) Generic Drugs Forum 2017 |
Conference/Workshop |
4/4/2017 |
Generic Drug Development |
Generic Labeling: Strategies for Providing High-quality Submissions (18/28) Generic Drugs Forum 2017 |
Conference/Workshop |
4/4/2017 |
Generic Drug Development; Labeling |
Panel Discussion (19/28) Generic Drugs Forum 2017 |
Conference/Workshop |
4/4/2017 |
Generic Drug Development |
OPQ Integrated Quality Assessment (IQA) Process (20/28) Generic Drugs Forum 2017 |
Conference/Workshop |
4/4/2017 |
Generic Drug Development; Drug Quality |
OPQ Communications with Industry (21/28) Generic Drugs Forum 2017 |
Conference/Workshop |
4/4/2017 |
Generic Drug Development; Drug Quality |
Drug Substance Review - ANDA (22/28) Generic Drugs Forum 2017 |
Conference/Workshop |
4/4/2017 |
Generic Drug Development; Drug Quality |
Generic Drug Product Quality Review (23/28) Generic Drugs Forum 2017 |
Conference/Workshop |
4/4/2017 |
Generic Drug Development; Drug Quality |
Dissolution Method Development for Generic Drugs (24/28) Generic Drugs Forum 2017 |
Conference/Workshop |
4/4/2017 |
Generic Drug Development; Drug Quality |
Manufacturing Process and Controls (25/28) Generic Drugs Forum 2017 |
Conference/Workshop |
4/4/2017 |
Generic Drug Development; Drug Quality |
Facility Evaluation and Inspection (26/28) Generic Drugs Forum 2017 |
Conference/Workshop |
4/4/2017 |
Generic Drug Development; Drug Quality; Inspections |
Product Quality Microbiology Assessment (27/28) Generic Drugs Forum 2017 |
Conference/Workshop |
4/4/2017 |
Generic Drug Development; Drug Quality |
Panel Discussion (28/28) Generic Drugs Forum 2017 |
Conference/Workshop |
4/4/2017 |
Generic Drug Development; Drug Quality; Inspections |
CDER Microbiology Issues: A Deeper Dive |
Webinar |
3/15/2017 |
Drug Quality |
Microbiology Assessment: Recommendations for Nonsterile Products (1/6) Microbiology Webinar |
Webinar |
3/15/2017 |
Drug Quality |
Case Study: Micro Investigation of Contamination by Burkholderia multivorans (2/6) Microbiology Webinar |
Webinar |
3/15/2017 |
Drug Quality |
Panel Questions and Discussion (3/6) CDER Microbiology Webinar |
Webinar |
3/15/2017 |
Drug Quality |
Building a Better Sterility Assurance Application (4/6) CDER Microbiology Webinar |
Webinar |
3/15/2017 |
Drug Quality |
Aseptic Processing of Biological Products: Regulatory Issues (5/6) Microbiology Webinar |
Webinar |
3/15/2017 |
Drug Quality |
Panel Questions and Discussion (6/6) CDER Microbiology Webinar |
Webinar |
3/15/2017 |
Drug Quality |
Draft Guidance for Industry: Referencing Approved Drug Products in ANDA Submissions |
Webinar |
3/6/2017 |
Generic Drug Development |
Best Practices for Communication Between FDA and IND Sponsors During Drug Development: CDERLearn Course Certificates of completion and embedded videos are no longer available. |
CDERLearn Course |
2/1/2017 |
FDA Meetings/Communications; IND |
FDA Addresses Small Business Concerns in GDUFA II |
SBIA Chronicles |
1/26/2017 |
Generic Drug Development |
FDA Addresses Small Business Concerns in GDUFA II |
SBIA Chronicles Podcast |
1/26/2017 |
Generic Drug Development |
FDA's Role in Public Health: Drug Efficacy, Safety, Quality, and Beyond: CDERLearn Course Certificates of completion and embedded videos are no longer available. |
CDERLearn Course |
6/7/2021 |
New Drug Development; Safety; Quality |
GDUFA Self-Identification (SPL) Submission – Part 1: CDERLearn Course Certificates of completion and embedded videos are no longer available. |
CDERLearn Course |
1/12/2016 |
Generic Drug Development; Regulatory Submissions |
GDUFA Self-Identification (SPL) Submission – Part 2: CDERLearn Course Certificates of completion and embedded videos are no longer available. |
CDERLearn Course |
1/12/2016 |
Generic Drug Development; Regulatory Submissions |
Overview of the Generic Drug User Fee Amendments of 2012 (GDUFA): CDERLearn Course Certificates of completion and embedded videos are no longer available. |
CDERLearn Course |
1/12/2016 |
Generic Drug Development; User Fees |
Case Studies in FDA's Drug Regulatory Processes: CDERLearn Course Certificates of completion and embedded videos are no longer available. |
CDERLearn Course |
10/22/2015 |
New Drug Development; NDA; IND |
Engaging with the FDA During New Drug Development Certificates of completion and embedded videos are no longer available. |
CDERLearn Course |
9/26/2014 |
New Drug Development; FDA Meetings/Communications |
Chemistry, Manufacturing, and Controls (CMC) Perspective of the IND: CDERLearn Course Certificates of completion and embedded videos are no longer available. |
CDERLearn Course |
9/17/2014 |
New Drug Development; Drug Quality |
Bringing an Over-the-Counter Drug to Market: CDERLearn Course Certificates of completion and embedded videos are no longer available. |
CDERLearn Course |
2/7/2013 |
OTC Drug Regulation |
CDER Presentations Library |
Webinar |
|
New Drug Development; Generic Drug Development; Biosimilars; Clinical Trials and Research |
CDER Webinars |
Webinar |
|
New Drug Development; Generic Drug Development; Biosimilars; Clinical Trials and Research |
Guidance Webinar Series |
Webinar |
|
New Drug Development; Generic Drug Development; Biosimilars; Clinical Trials and Research |