Thalidomide distribution with Accutane pregnancy prevention model recommended by FDA advisory cmte..
Executive Summary
THALIDOMIDE DISTRIBUTION WITH ACCUTANE PREGNANCY PREVENTION MODEL and tracking was recommended by FDA's Dermatologic & Ophthalmic Drugs Advisory Committee Nov. 8. FDA convened the advisory committee to discuss required post-marketing programs and monitoring to address thalidomide's known teratogenicity and peripheral neuropathic effects.