FDA releases fresh details on internal debate over controversial Alzheimer’s drug

But in an interview Tuesday, acting FDA commissioner Janet Woodcock, who said she was not involved in the approval, defended the approach, saying she was “fairly confident” that reducing amyloid would help patients’ cognition. She noted that under accelerated approval, officials can approve a drug based on a surrogate endpoint — in this case, a reduction in amyloid — if it is “reasonably likely” to produce a clinical benefit.

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