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All Lessons

Mastering Controlled Correspondences: What, When, and How

Medical Device Reporting: Viewing Adverse Events as Opportunities for Transformation

Minor Regulatory Errors with Major Consequences

Model Master Files: How to Develop and Submit One? 

mRNA Vaccines (Clinical Investigator Training Course 2024)

Navigating Challenges in Drug Manufacturing: Common Process Deficiencies and Pre-Approval Inspection Observations

Navigating Formulation Assessment: Considerations for Products that are Not Required to be Q1/Q2

Navigating Formulation Assessment: Considerations When Preparing the Q1/Q2 Sameness Inquiry

Nitrosamine Related Guidance

Office of Generic Drugs Keynote (Generic Drugs Forum 2025)

Office of Pharmaceutical Quality Keynote (Generic Drugs Forum 2025)

Orange Book Marketing Status

Overview of CBER’s Office of Communication, Outreach and Development

Overview of ICH M13 Guideline Series

Patient Engagement (REdI 2024 – Biologics Track)

Pharmacology & Toxicology in the Investigator’s Brochure

Plenary (REdI 2024 Conference)

Postmarketing Surveillance for Product Safety in Pregnancy (REdI 2024 – Biologics Track)

Pre-Abbreviated New Drug Application (ANDA) Meetings: Process and Best Practices

Product Specific Guidance (PSG) Program Overview

Programs Next Steps & Poll Questions (BsUFA III Science Pilot Program: Progress Update)

Project Managing Drug Assessors Under GDUFA III Regulations

Q&A with Session Five Speakers (REdI 2024 – Biologics Track)

Q&A with Session Four Speakers (REdI 2024 – Biologics Track)

Q&A with Session One Speakers (REdI 2024 – Biologics Track)

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