FDA chief Janet Woodcock acknowledges agency may have misstepped in process leading up to Alzheimer’s drug approval

Stat News

14 July 2021 - Acting FDA Commissioner Janet Woodcock acknowledged on Wednesday her agency may have misstepped in its handling of its polarising approval of a new Alzheimer’s drug.

She was emphatic in her defence of the therapy and the agency’s approval decision in an interview at STAT’s Breakthrough Science Summit, but said “it’s possible that the process could have been handled in a way that would have decreased the amount of controversy involved.”

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Michael Wonder

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Michael Wonder

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Medicine , US , Regulation