FDA’s expansive Alzheimer’s drug approval surprised even top agency officials

Stat News

9 July 2021 - The FDA’s contentious decision to approve a new Alzheimer’s drug for every single patient with the disease surprised even top FDA officials involved in deliberations about the approval process.

One of the sources went further, saying they would never have supported the faster approval process that the FDA employed had they known the agency was considering such a broad patient population.

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Michael Wonder

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Michael Wonder

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Medicine , US , Regulation