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All Lessons

Day Two Closing Remarks (Advancing Generic Drug Development 2024)

Day Two Q&A Session with Panel & Closing (Particle Size Analysis)

Deep Dive into 483 Observations

Development of Generic Drug Products Under Suitability Petition

Device and User Interface Assessment Recommendations in Drug-Device Combination Product PSGs

Discussion Panel (M13A: Bioequivalence)

Discussion Panel (Navigating Controlled Correspondences)

Discussion Panel (OSIS)

Diversity in Clinical Trials: Drug Trials Snapshot Perspective 

Download Agenda & Presentation Slides (Pre-Sub Meetings)

Download Agenda & Presentation Slides (PSG)

Download Agenda & Speakers Biographies

Download Agenda, Slides & Transcript (BsUFA III Science Pilot Program: Progress Update)

Download Agenda, Slides & Transcript (FDA | NIH : Regulatory Do’s and Don’ts: Tips from FDA)

Download Agenda, Slides & Transcript (M13A)

Download Agenda, Slides & Transcript (Navigating Controlled Correspondences)

Download Agenda, Slides & Transcripts (Animal Drug User Fee Conference 2024)

Download Agenda, Slides & Transcripts (Clinical Investigator Training Course 2024)

Download Agenda, Slides & Transcripts (Generic Drugs Forum 2025)

Download Agenda, Slides & Transcripts (REdI 2024 – Biologics Track)

Download Agenda, Slides & Transcripts (REdI 2024 – Devices Track)

Download Agenda, Slides & Transcripts (REdI 2024 – Drugs Track)

Download Agenda, Slides and Transcript (OSIS)

Download Agenda, Slides, Speaker Bios & Transcript (Electronic Drug Registration and Listing 2024)

Download Agenda, Slides, Speaker Bios & Transcript (AGDD)

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