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FDA's accelerated approval proposal

Executive Summary

A draft regulation is reportedly at the Public Health Service for review. PHS is expected to distribute the draft to HHS, the Office of Management & Budget and other federal agencies for further comment. The draft reg reportedly provides for use of surrogate endpoints along with mandatory postmarketing studies to gain approval. The draft reg also would allow drugs with known safety risks to be cleared with restrictions on distribution, and allow FDA to expedite withdrawals, if necessary, of drugs that received accelerated approval. . . .
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PS019874

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