FDA's dilemma with the aducanumab approval: public pressure and hope, surrogate markers and efficacy, and possible next steps.
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DOI: 10.1136/bmjebm-2022-111914
Abstract: Accelerating Food and Drug Administration (FDA) product approval to market based on surrogate markers in the absence of proven efficacy creates a risk of adverse outcomes for affected patients, even in response to a life-threatening… read more here.
Keywords: dilemma aducanumab; approval public; surrogate markers; approval ... See more keywords