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All Lessons

Panel Discussion, Summary, and Close Out (Interchangeable Products)

Patient Engagement (REdI 2024 – Biologics Track)

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

Presentation Slides (Particle Size Analysis)

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

Public Comment Session & Session 3: Current Accessibility to Epinephrine for Treating Anaphylaxis

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)

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