Accutane risk management
Executive Summary
A Feb. 26-27 joint meeting of FDA's Drug Safety & Risk Management and Dermatologic & Ophthalmic Drugs Advisory Committees will discuss Roche's "SMART" (System to Manage Accutane Teratogenicity) program. Roche adopted SMART two years ago in an effort to prevent pregnancy in women taking the drug. FDA was expected to convene a meeting on Accutane this winter (1"The Pink Sheet" Nov. 24, 2003, p. 18). The committee will also discuss risk management for generic versions of the isotretinoin product. The meeting will be held at the Hilton in Gaithersburg, Md. beginning at 8 a.m. on both days. [To 2watch a webcast or arrange a live videoconference of this meeting, go to FDAAdvisoryCommittee.com]...
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