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All Lessons

Requesting a Labeler Code from FDA

Rx Drug Promotion and the Clear, Conspicuous, and Neutral Final Rule

Safety Considerations in Clinical Drug Development

Safety Considerations in Clinical Drug Development

Selective Safety Data Collection in Clinical Trials (REdI 2024 – Drugs Track)

Session 1: Panel Discussion (FDA Generic Drug Science Workshop 2025)

Session 1: Presentations (FDA Generic Drug Science Workshop 2025)

Session 1: Q&A Panel (Advancing Generic Drug Development 2025)

Session 1: Question & Answer Panel (Advancing Generic Drug Development 2024)

Session 1: Scientific and Regulatory Considerations for In Vitro Release Test (IVRT) for Complex Products

Session 2: Panel Discussion (FDA Generic Drug Science Workshop 2025)

Session 2: Presentations (FDA Generic Drug Science Workshop 2025)

Session 2: Q&A Panel and Day 1 Closing (Advancing Generic Drug Development 2025)

Session 2: Question & Answer Panel (Advancing Generic Drug Development 2024)

Session 2: Research to Support Guidance Development for Topical Drug Products

Session 3: Panel Discussion (FDA Generic Drug Science Workshop 2025)

Session 3: Presentations (FDA Generic Drug Science Workshop 2025)

Session 3: Q&A Panel (Advancing Generic Drug Development 2025)

Session 3: Question & Answer Panel (Advancing Generic Drug Development 2024)

Session 3: Research to Support Guidance Development for Inhalation Drug Products

Session 4: Outlook for Drug-Device Combination Products

Session 4: Panel Discussion (FDA Generic Drug Science Workshop 2025)

Session 4: Presentations (FDA Generic Drug Science Workshop 2025)

Session 4: Q&A Panel and Day Two Closing (Advancing Generic Drug Development 2025)

Session 4: Question & Answer Panel (Advancing Generic Drug Development 2024)

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