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

WASHINGTON — The Food and Drug Administration’s contentious decision to approve a new Alzheimer’s drug for every single patient with the disease surprised even top FDA officials involved in the deliberations, two senior staffers told STAT.

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

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