FDA Direct - Special Edition of FDA Direct

Recapping a year's worth of progress, taking a moment to recognize our amazing staff, and discussing what's next for the FDA.

FDA Direct: Combating Rare Diseases at the FDA
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FDA Direct: Combating Rare Diseases at the FDA

FDA Direct: Who Buys the Spin — Hook, Line and Sinker?
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FDA Direct: Who Buys the Spin — Hook, Line and Sinker?

Advancing Real-Time Clinical Trials
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Advancing Real-Time Clinical Trials

Adeno-Associated Virus-Mediated Gene Therapy - Advances, Immune Challenges, and Research Innovations
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Adeno-Associated Virus-Mediated Gene Therapy - Advances, Immune Challenges, and Research Innovations

Commissioner’s National Priority Voucher (CNPV) Pilot Program Public Hearing
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Commissioner’s National Priority Voucher (CNPV) Pilot Program Public Hearing

FDA Direct: What's the Deal with Talc? - Recapping
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FDA Direct: What's the Deal with Talc? - Recapping

FDA Direct: Dramatically lowering drug prices for Americans
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FDA Direct: Dramatically lowering drug prices for Americans

OTP Town Hall: Best Practices for Preparing BLA Submissions for Cell and Gene Therapy Products
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OTP Town Hall: Best Practices for Preparing BLA Submissions for Cell and Gene Therapy Products

Understanding the Nutrition Facts Label, the Updated “Healthy” Claim, and Other Nutrition Claims
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Understanding the Nutrition Facts Label, the Updated “Healthy” Claim, and Other Nutrition Claims

FDA Direct: The Power of Real-Time Clinical Trials
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FDA Direct: The Power of Real-Time Clinical Trials

FDA Direct: These 9 Drugs Were Awarded National Priority Vouchers
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FDA Direct: These 9 Drugs Were Awarded National Priority Vouchers

FDA Direct: Catching Up on Agency Reforms
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FDA Direct: Catching Up on Agency Reforms

FDA Grand Rounds - Clinical Omics Biomarker Discovery and Validation in Precision Medicine
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FDA Grand Rounds - Clinical Omics Biomarker Discovery and Validation in Precision Medicine

FDA Direct: FDA is Not Your Doctor - Discussing FDA's Role and Mandate
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FDA Direct: FDA is Not Your Doctor - Discussing FDA's Role and Mandate

CDRH - REdI Annual Conference 2026: Innovative Regulatory Strategies to Advance Medical Products
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CDRH - REdI Annual Conference 2026: Innovative Regulatory Strategies to Advance Medical Products

FDA Direct: Faster Reviews, Food Dye Wins and Protecting American DNA
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FDA Direct: Faster Reviews, Food Dye Wins and Protecting American DNA

VRBPAC -- May 28 Meeting
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VRBPAC -- May 28 Meeting

FDA Direct: No One Think It's a Good Idea for Kids to Consume Petroleum Products
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FDA Direct: No One Think It's a Good Idea for Kids to Consume Petroleum Products

FDA Direct, Striking a Balance - Framework for Future Covid-19 Vaccine Decisions
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FDA Direct, Striking a Balance - Framework for Future Covid-19 Vaccine Decisions

CDER - REdI Annual Conference 2026: Innovative Regulatory Strategies to Advance Medical Products
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CDER - REdI Annual Conference 2026: Innovative Regulatory Strategies to Advance Medical Products