Increasing the Efficiency of Biosimilar Development Programs (Day 1)
The U.S. Food and Drug Administration (FDA) and the International Pharmaceutical Regulators Program (IPRP) Biosimilars Working Group (BWG) hosted a virtual workshop "Increasing the Efficiency of Biosimilar Development Programs – Reevaluating the Need for Comparative Clinical Efficacy Studies" on September 12-13, 2023. This video shows Day 1 of the public sessions of the workshop. For more information, visit: https://www.fda.gov/drugs/news-events...
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Increasing the Efficiency of Biosimilar Development Programs (Day 2)
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Expanded Access to Investigational Drugs for Treatment Use - Questions and Answers
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FDA Direct - Special Edition of FDA Direct
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AGDD 2025 | D1S01 - Product-Specific Guidance for Complex Products: From Research to Standards
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AGDD 2025 | D2S03 - Common Deficiencies and Resolutions: Complex Drug Substance/Excipients/Products
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OTP Town Hall: Best Practices for Preparing BLA Submissions for Cell and Gene Therapy Products
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AGDD 2025 | D1S02 - Novel Bioequivalence Study Design Recommendations
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AGDD 2025 | D2S04 - Nitrosamines: Known Issues and Practical Advice
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FDA Grand Rounds - Pharmacovigilance in Practice: From Safety Signals to Regulatory Action
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Understanding Endpoints in Rare Disease Drug Development
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Commissioner’s National Priority Voucher (CNPV) Pilot Program Public Hearing
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FDA Direct: Faster Reviews, Food Dye Wins and Protecting American DNA
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AGDD 2025 | D1S01 – Session 1: Q&A Discussion Panel
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Conversations on Cancer: Patient first = Project Facilitate
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FDA Grand Rounds: FDA Menopausal Hormone Therapy (MHT) Labeling: Historical Context & Recent Changes
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AGDD 2025 | D2S03-1 Session 3: Q&A Discussion Panel
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AGDD 2025 | D1S00 - Welcome and Opening Remarks
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