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All Lessons

Pharm/Tox Considerations for the Safety Evaluation of Nitrosamine Impurities

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

Pre-Submission Meetings: Scenario Discussion

Presentations: CFSAN Updated “Healthy” Nutrient Content Claim: Final Rule

Product Specific Guidance (PSG) Program Overview

Product-Specific Guidance Revisions: Update on Metered Dose Inhaler & Dry Powder Inhaler

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

Project Managing Drug Assessors Under GDUFA III Regulations

PSG Program: Updates and Overview of Available Resources

Q&A Session 1-1 (FDA Compounding Conference 2025)

Q&A Session 1-2 (FDA Compounding Conference 2025)

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)

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

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

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

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

Question & Answer Panel One (Electronic Drug Registration and Listing 2024)

Question & Answer Panel Two (Electronic Drug Registration and Listing 2024)

Question & Answer Session (IDMP)

Question & Answer Session (M13A: Bioequivalence)

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