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US FDA Advisory Committees As The Court Of Appeals

 
• By Michael McCaughan

The US FDA’s use of its advisory committees continues to shrink. In 2022, the expert panels appear primarily to serve as a last chance for sponsors to prevent (or overturn) an FDA rejection.

FDA court of appeals
Is this what advisory committees have become? • Source: Nielsen Hobbs; the Pink Sheet | Shutterstock image

The US Food & Drug Administration is planning to keep is outside advisors on vaccines very busy in June, with as many as four high profile topics up for consideration.

But as busy as things will seem next month, the reality remains that FDA is using its outside advisory committees very sparingly. Never have so few new drug applications gone to the public review stage prior to approval – at least, never since Congress formally encourage FDA to take all new molecular entities to committee in 2007

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• By Bridget Silverman

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Maybe In May: US FDA Calls Coming On Moderna Next-Gen COVID-19 Vaccine, AbbVie’s Big ADC Bet

 
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AMR-Targeting Drug Secures EMA PRIME Designation

 
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US FDA’s Review Performance Held Steady Despite Stormy First Quarter

 
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Organizational turmoil has not yet affected reviews of novel agent applications, with Q1 2025 approvals coming in low, but the first quarter share of the entire year is variable.

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Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

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