FDA ACCELERATED APPROVAL ADVISORY COMMITTEE PROPOSED
FDA ACCELERATED APPROVAL ADVISORY COMMITTEE PROPOSED by a group of AIDS treatment activists, led by Derek Link, Gay Men's Health Crisis, in a Jan. 3. memo to FDA Commissioner Kessler. An advisory committee established to discuss the impact of accelerated approval on the development of AIDS therapeutics should be created by FDA, the coalition suggested, and should convene to discuss the "broader impact of accelerated approval on trial design and drug development, recent discouraging nucleoside data, and the state of surrogate markers." In addition, the group recommended that "the meeting needs to be free from a specific drug approval decision, and should focus on developing a consistent framework for considering future accelerated NDAs."
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