Autopsy of a drug withdrawal — the case of melphalan flufenamide

New England Journal of Medicine

7 December 2024 - The accelerated approval pathway, which was established in 1992, has expedited approvals of drugs for serious and life-threatening diseases, with decisions being made on the basis of an intermediate clinical end point or a surrogate end point that is reasonably likely to predict clinical benefit. 

When confirmatory trials don’t verify a drug’s clinical benefit or there are other legal grounds for withdrawal, the FDA may withdraw the approval.

Read New England Journal of Medicine Perspective

Michael Wonder

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Michael Wonder

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Cancer , Medicine , US , Regulation , Withdrawal