CDER Webinars
Upcoming Webinars
- FDA Drug Topics: FDA Drug Information Resources and Applicability to Health Care Professionals – April 26, 2022
Past 2022 Webinars
- FDA Drug Topics: Counseling Patients on Generic Drugs – February 22, 2022
- Biosimilar and Interchangeable Biosimilars: Review of Scientific Concepts, Case Studies, and Resources
Past 2021 Webinars
- FDA Drug Topics: Overview of Expanded Access (EA) Program and EA eRequest Site – December 14, 2021
- Clinical Investigator Training Course (CITC) Update - December 7-8, 2021
- Fraudulent Products – Hidden Ingredients and Unproven Claims in Products Marketed as Dietary Supplements
- How FDA and ISMP Utilize Medication Error Reports to Improve Drug Safety
- Electronic Drug Registration and Listing (eDRLS) Using CDER Direct - 10/13/2021 - 10/13/2021
- Enhanced Drug Distribution Security in 2023 Under the DSCSA - October 5, 2021
- Investigator Responsibilities — Safety Reporting for Investigational Drugs and Device
- FDA’s Role in Postmarketing Drug Safety Surveillance
- Overview of Risk Evaluation and Mitigation Strategies (REMS) for Health Care Providers
- OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2021 User Fees Webinar - 06/03/2021 - 06/03/2021
- Enhanced Drug Distribution Security: 2023 and Beyond
- Safety Labeling Changes for Leukotriene Receptor Antagonists and Decisions Behind a Boxed Warning
- FDA’s Office of Orphan Products Development (OOPD) – An Overview and Update
- The Ins and Outs of Prescription Drug Labeling
- Biosimilar and Interchangeable Biological Products: An Updated Review of Scientific Concepts and Practical Resources
Past 2020 Webinars
- Project Facilitate: Oncology Expanded Access Program Update
- Orange Book: Frequently Asked Questions and Answers
- Labeling Made Simple: The How, What, and Where of Drug Interactions in Prescribing Information
- An Overview of Naloxone and FDA’s Efforts to Expand Access
- FDA Drug Topics: Role of FDA and ISMP in Preventing Medication Errors – June 30, 2020 (Postponed from March 17, 2020)
- Webinar: CDER SEND Common Issues and Policy Update - June 15, 2020
- CURE ID: Capturing Clinician’s Experiences Repurposing Drugs to Inform Future Studies in the Era of COVID-19
- FDA’s Bad Ad Program
- Nitrosamine Impurities in Drugs: What Health Care Professionals Need to Know
- Postmarketing Drug Safety Compliance: 2019 Inspection Findings – Apr. 29, 2020
- CDER SEND Common Issues and Policy Update - March 20, 2020
- Learn About ClinicalTrials.gov Modernization and How to Provide Input - March 2, 2020
- FDA Drug Information Resources and Applicability to Health Care Professionals
- On Demand Webinar: Recent Revisions to the ANDA Prioritization MAPP – Jan. 2020
- Research Funding Opportunities to Reduce Preventable Harm
Past 2019 Webinars
- Webinar: Submitting IND Safety Reports to FDA Adverse Event Reporting System (FAERS) - Nov. 1, 2019
- Webinar: Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting System (FAERS) using International Council for Harmonisation (ICH) E2B(R3) Standards - Oct. 11, 2019
- Most Common Issues with CDISC-SEND Data in FDA Toxicology Review – Sep. 12, 2019
- On-demand Webinar: eCTD Submissions of Promotional Labeling and Advertising Materials – Aug. 12, 2019
- FDA Drug Topics: 3D Printing in Drug Development and Emerging Health Care – May 21, 2019
- An Introduction to FDA MyStudies: An Open-Source, Digital Platform to Gather Real World Data for Clinical Trials and Research Studies – May 9, 2019
- Webinar: Risk-Based Approach to Monitoring Clinical Investigations: Overview of FDA Draft Guidance Issued for Comment
- FDA Drug Topics: An Overview of Pharmacovigilance in the Center for Drug Evaluation and Research (CDER) – March 26, 2019
- Webinar: Framework for FDA’s Real-World Evidence Program – Mar 15, 2019
Past 2018 Webinars
- FDA Drug Topics: Biosimilar and Interchangeable Products in the U.S.: Scientific Concepts, Clinical Use, and Practical Considerations – December 10, 2018
- Final Guidance for Industry: Use of Electronic Health Record Data in Clinical Investigations – December 6, 2018
- FDA Study Data Technical Conformance Guide – November 27, 2018
- FDA Drug Topics: FDA Regulation of Color Additives in Drug Products – November 6, 2018
- An update to the FDA Adverse Event Reporting System (FAERS) Public Dashboard
- Writing the “Indications and Usage” Section of Labeling: FDA’s New Draft Guidance
- Building Confidence in Generic Narrow Therapeutic Index (NTI) Drugs
- Deeper Dive Webinar: Postmarketing Drug Safety and Inspection Readiness - June 19, 2018
- Updates to Forms 356h & 1571: Commercial vs. Research, Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT), Combination Products
- Optimizing Your Study Data Submissions to FDA: Office of Vaccines Research and Review (OVRR) Data Submission - May 8, 2018
- FDA Drug Topics: FDA's MedWatch Adverse Event Reporting Program â Opportunities to Collaborate - March 13, 2018
- FDA Drug Topics: FDA Adverse Events Reporting System (FAERS) Public Dashboard - January 30, 2018
Past 2017 Webinars
- CDER Small Business and Industry Assistance (CDER SBIA) Webinar - Draft guidance for Industry: Information Requests and Discipline Review Letters Under GDUFA - December 15, 2017
- DDI Webinar Series: Overview of the Regulatory Framework and the Development and Approval of Biosimilar Products in the U.S. - December 5, 2017
- CDER Small Business and Industry Assistance (CDER SBIA) Webinar - REMS Integration Initiative: An Overview - December 4, 2017
- DDI Webinar Series: Tainted Products Marketed as Dietary Supplements - November 21, 2017
- CDER Small Business and Industry Assistance (CDER SBIA) Webinar - Optimizing Your Study Data Submissions to FDA - Study Data Technical Conformance Guide October 2017 Version Update - November 8, 2017
- CDER Small Business and Industry Assistance (CDER SBIA) Webinar - Draft Guidance for Industry: Controlled Correspondence Related to Generic Drug Development
- DDI Webinar Series: An Overview of FDA Resources - October 17, 2017
- CDER Small Business and Industry Assistance (CDER SBIA) Webinar - Draft Guidance for Industry: Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA
- CDER Small Business and Industry Assistance (CDER SBIA) Webinar - Draft Guidance for Industry: Determining Whether to Submit an ANDA or 505(b)(2) Application
- CDER Small Business and Industry Assistance (CDER SBIA) Webinar - Draft Guidance for Industry: ANDA Submissions â Amendments to Abbreviated New Drug Applications Under GDUFA II
- CDER SBIA extended webinar: Electronic Drug Registration & Listing Using CDER Direct - October 5, 2017
- CDER Small Business and Industry Assistance (CDER SBIA) Webinar - Draft Guidance for Industry: Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA
- CDER Small Business and Industry Assistance (CDER SBIA) Webinar - Optimizing Your Study Data Submissions to FDA â Updates from CDER and CBER - July 13th 2017 - 1:00pm - 2:45pm (Eastern)
- CDER Small Business and Industry Assistance (CDER SBIA) Webinar - The Ins and Outs of Presenting Clinical Pharmacology Information in Prescription Drug Labeling - June 19th 2017 - 1:00pm - 2:30pm (Eastern)
- CDER Small Business and Industry Assistance (CDER SBIA) Webinar - Risk Evaluation and Mitigation Strategies (REMS): A Deeper Dive - June 15th 2017 - 12:00pm - 3:00pm (Eastern)
- DDI Webinar Series: Fluoroquinolone Safety Labeling Updates- April 4, 2017
- CDER Small Business and Industry Assistance (CDER SBIA) Webinar - CDER Microbiology Issues: A Deeper Dive - March 15th, 2017
- DDI Webinar Series: FDA Post-Marketing Drug Safety Surveillance- March 7, 2017
- DDI Webinar Series: âCollaborating with FDA- Get Involved with FDAâs MedWatch Adverse Event Reporting Programâ- February 7, 2017
- CDER Small Business and Industry Assistance (CDER SBIA) Webinar - Draft Guidance for Industry: Referencing Approved Drug Products in ANDA Submissions
Past 2016 Webinars
- CDER Small Business and Industry Assistance (CDER SBIA) Webinar - Annual Reporting Using CDER Direct: Technical Tips for Wholesale Drug Distributors and Third-Party Logistics Providers
- CDER Small Business and Industry Assistance (CDER SBIA) Webinar - An Overview of FDA's Guidance - Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification
- DDI Webinar Series: "Understanding Abuse Deterrent Opioids"- December 8, 2016
- CDER Small Business and Industry Assistance (CDER SBIA) Webinar - Revised Draft Guidance for Industry: Submission of Quality Metrics Data
- CDER Small Business and Industry Assistance (CDER SBIA) Webinar - What's New with Forms FDA 3542a and 3542?
- CDER Small Business and Industry Assistance (CDER SBIA) Webinar - Electronic Submission Requirements for ANDAs: Are You Ready? - November 21, 2016
- DDI Webinar Series: "The Etiologies of Drug Shortages"- November 8, 2016
- CDER Small Business and Industry Assistance (CDER SBIA) Webinar - Overview of GDUFA II and Implementation of GDUFA II User Fees - October 28, 2016
- CDER Small Business and Industry Assistance (CDER SBIA) Webinar - Study Data Standards in eCTD: What You Need to Know about the New Technical Rejection Criteria - October 12, 2016
- DDI Webinar Series: "FDA's Bad Ad Program and other Innovative FDA Collaborations" - October 6, 2016
- CDER Small Business and Industry Assistance (CDER SBIA) Webinar - Establishment Registration and Listing for Human Drugs
- CDER Small Business and Industry Assistance (CDER SBIA) Webinar - Submitting Risk Evaluation and Mitigation Strategies (REMS) in Structured Product Labeling (SPL) Format: What You Need to Know - August 24, 2016
- CDER Small Business and Industry Assistance (CDER SBIA) Webinar: Stay Compliant! Electronic Submission of Drug Master Files (DMFs) is MANDATORY starting May 5, 2017: What You Need to Know - August 4, 2016
- CDER Small Business and Industry Assistance (SBIA) Webinar: CDER Direct Electronic Submission Portal: 503B Product Reporting (Compounding)
- DDI Webinar- "An Overview of FDA's Expanded Access Process and the New Individual Patient Expanded Access Application" - July 12, 2016
- DDI Webinar- "The Pregnancy and Lactation Labeling Rule (PLLR)" - April 14, 2016
- CDER Small Business and Industry Assistance (CDER SBIA) Webinar â Pilot Clinical Outcome Assessment Compendium - March 8th, 2016
- DDI Webinar-"Introduction to Post-Marketing Drug Safety Surveillance: Pharmacovigilance in FDA/CDER" - February 23, 2016
- DDI Webinar- "Introduction to FDAâs MedWatch Adverse Reporting Program" - February 9, 2016
- CDER Small Business and Industry Assistance (CDER SBIA) Webinar - New Requirement for Electronic Submission of Drug Master Files (DMFs): What You Need to Know - February 4, 2016
- CDER Small Business and Industry Assistance (CDER SBIA) Webinar - Draft Guidance for Industry on Safety Assessment for IND Safety Reporting - February 1, 2016
Resources For You
2013-2015 webinar pages are archived. To view them, please see the FDA Archive.
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