SBIA Webinars
2021 Webinars
- Identification of Medicinal Products: Path to Global Implementation - June 11, 2021
- OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2021 User Fees Webinar - 06/03/2021 - 06/03/2021
- FDA and Health Canada Regional ICH Consultation - May 24, 2021
- FDA Study Data Technical Rejection Criteria (TRC): What you need to know! - May 21, 2021
- FDA Product-Specific Guidances: Lighting the Development Pathway for Generic Drugs - May 5, 2021
- Common Labeling Deficiencies and Tips for Generic Drug Applications - May 7, 2021
- Drug Master File (DMF) and Drug Substance Question and Answer Webinar Following March 3-4, 2021 Workshop - April 9, 2021
- FDA Safety Report Type Flag Requirement for FAERS Submissions - February 29, 2021
- Regulatory Perspectives for Development of Drugs for Treatment of NASH - January 29, 2021
- OTC Monograph Reform in the CARES Act: Safety Orders - January 27, 2021
- Drug Master File (DMF) Submissions on New FDA Form 3938 - January 13, 2021
2020 Webinars
- Diversity in Clinical Trials: Learn about Enrollment Trends and Resources from FDA - December 16, 2020
- SEND for CBER, What You Need to Know - December 4, 2020
- Guidance for Industry: Referencing Approved Drug Products in ANDA Submissions - November 20, 2020
- Office of Prescription Drug Promotion - Core Launch Review Process - November 20, 2020
- Bridging the Gap – Promoting Safe and Effective Prescription Drug Use in Geriatric Patients - November 13, 2020
- SBIA Webinar: FDA Announces Quality Management Maturity Programs - November 12, 2020
- Office of New Drug (OND) Research: Seeking Collaborators, Funding Opportunities Available - November 6, 2020
- New Approaches for an Integrated Nonclinical-Clinical QT/Proarrhythmic Risk Assessment - October 15-16, 2020
- Overview of the Guidance for Industry: Control of Nitrosamine Impurities in Human Drugs - October 2, 2020
- Cannabis Clinical Research: Drug Master Files (DMFs) & Quality Considerations - September 16, 2020
- A Pharmaceutical Quality Webinar for Global Stakeholders - July 23, 2020
- Webinar: CDER SEND Common Issues and Policy Update - June 15, 2020
- Still submitting paper to CDER? Send electronically with CDER’s NextGen Portal instead! (for submissions not required in eCTD) - May 27, 2020
- Webinar: Monograph reform is here! Learn what to expect and how to prepare - May 29, 2020
- SBIA Webinar: Conducting Clinical Trials During the COVID-19 Public Health Emergency - April 30, 2020
- Webinar: Postmarketing Drug Safety Compliance: 2019 Inspection Findings - April 29, 2020
- CDER SBIA Webinar: Updates on FDA’s Drug-Drug Interaction Final Guidances - April 24, 2020
- Webinar: Learn About ClinicalTrials.gov Modernization and How to Provide Input - March 6, 2020
- On Demand Webinar: Recent Revisions to the ANDA Prioritization MAPP – January 2020
Past 2019 Webinars
- On Demand Webinar: What is new with Forms FDA 3542a and 3542? (December 2019)
- The FDA Study Data Technical Conformance Guide v4.4 - Nov 22, 2019
- Webinar: Submitting IND Safety Reports to FDA Adverse Event Reporting System (FAERS)- Nov. 1, 2019
- Webinar: Technical Specifications for Submitting Data for QT Studies - Nov. 8, 2019
- Webinar: OPDP Electronic Submissions – Common Errors in eCTD and How to Avoid Them- Oct. 25, 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
- Regulatory Education for Industry (REdI): How should I measure this? An FDA perspective on the Bioanalytical Method Validation (BMV) – June 17, 2019
- Regulatory Education for Industry (REdI) Webinar: Identification of Medicinal Products (IDMP): What is IDMP and Why Should I Care? – June 13, 2019
- Regulatory Education for Industry (REdI) Webinar: Financial Incentives for CDER Medical Products – June 10, 2019
- Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics: Overview of FDA Draft Guidance Issued for Comment– May 13, 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
- CDER Small Business and Industry Assistance (SBIA) Webinar: Framework for FDA’s Real-World Evidence Program – Mar 15, 2019
Past 2018 Webinars
- CDER Small Business and Industry Assistance (CDER SBIA) Webinar - Final Guidance for Industry: Use of Electronic Health Record Data in Clinical Investigations – December 6, 2018
- CDER Small Business and Industry Assistance (CDER SBIA) Webinar - FDA Study Data Technical Conformance Guide – November 27, 2018
- Writing the “Indications and Usage” Section of Labeling: FDA’s New Draft Guidance Webinar - September 27, 2018
- Deeper Dive Webinar: Postmarketing Drug Safety and Inspection Readiness - June 19, 2018
- CDER Small Business and Industry Assistance (CDER SBIA) Webinar - CBER Update: Office of Vaccines Research and Review (OVRR) Data Submission - May 8, 2018
- CDER Small Business and Industry Assistance (CDER SBIA) Webinar - Updates to Forms 356h & 1571: Commercial vs. Research Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT) Combination Products
Archive
2011-2015 webinar pages are archived. To view them, please see the FDA Archive.
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