
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 deliberations about the approval process, 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.
Create a display name to comment
This name will appear with your comment