How does the FDA approve new drugs?
Prescription drugs go through many steps and phases before they’re approved by the FDA, from research to clinical trials. What does this process look like from beginning to end? Learn more in this short video from FDA’s Center for Drug Evaluation and Research (CDER).
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CDER - REdI Annual Conference 2026: Innovative Regulatory Strategies to Advance Medical Products
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FDA Direct: The Power of Real-Time Clinical Trials
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Investigational New Drug (IND) Submission: Content/Format and First 30 Days (5of14) REdI 2018
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CBER - REdI Annual Conference 2026: Innovative Regulatory Strategies to Advance Medical Products
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CDER & CBER All Hands: Implementing the FDA's Plausible Mechanism Framework
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VRBPAC -- May 28 Meeting
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Commissioner’s National Priority Voucher (CNPV) Pilot Program Public Hearing
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April 30, 2026 Meeting of the Oncologic Drugs Advisory Committee (ODAC)
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FDA Direct - Special Edition of FDA Direct
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Ebola Survivor - Dr. Ian Crozier
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CDER - REdI Annual Conference 2026: Innovative Regulatory Strategies to Advance Medical Products
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What is FDA’s role in regulating drugs?
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FDA Direct: Combating Rare Diseases at the FDA
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OTP Town Hall: Best Practices for Preparing BLA Submissions for Cell and Gene Therapy Products
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Advancing Real-Time Clinical Trials
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FDA Direct: Who Buys the Spin — Hook, Line and Sinker?
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CDRH - REdI Annual Conference 2026: Innovative Regulatory Strategies to Advance Medical Products
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FDA Direct: These 9 Drugs Were Awarded National Priority Vouchers
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Introduction to Investigational New Drug (IND) Applications (3/14) REdI 2017
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