Accelerated approval Phase IV commitments
Executive Summary
FDA's Oncologic Drugs Advisory Committee will meet Nov. 8 to review unfulfilled Phase IV commitments of accelerated approval oncologic drug products. The committee will "identify difficulties associated with completion" of the commitments and provide "advice to sponsors to assist in the planning and execution of postmarketing commitments of newly approved drugs," FDA says. The status of Phase IV commitments for Johnson & Johnson/Alza's Doxil, MedImmune's Ethyol, Ligand/Seragen's Ontak, SkyePharma's DepoCyt, Pfizer's Celebrex, Wyeth's Mylotarg, and Genzyme/Ilex' Campath will be reviewed. Office of Oncology Drugs Director Richard Pazdur said there would be a meeting on the topic during the Sept. 14 review of GlaxoSmithKline's Arranon (1"The Pink Sheet" Sept. 26, 2005, p. 27). The meeting will be held at the Holiday Inn in Gaithersburg, Md. beginning at at 8 a.m.[Editor's Note: To 2watch a webcastor order a video/DVD of this meeting, visit FDAAdvisoryCommittee.com]...
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