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US FDA Calls ’Em Like Its Advisory Committees See Them

 
• By Bridget Silverman

So far this year, when the agency has taken action on NMEs that went before advisory committees, the FDA decision has matched the committee vote.

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Is Lykos Therapeutics’ MDMA application headed for strike one? • Source: Shutterstock

The US FDA convened five advisory committee meetings to discuss NMEs and novel biologics during the first half of the year. Two of the meetings took place after the user fee goal date had passed, suggesting the value that the FDA places on scientific advice for challenging applications.

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