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iPLEDGE gets another committee review

Executive Summary

FDA's Dermatologic and Ophthalmic Drugs Advisory Committee will meet Aug. 1 to provide updates on risk management activities for the acne therapy isotretinoin (Roche's Accutane and generics). The iPLEDGE program requires manufacturers of the product to submit reports to FDA to ensure drug exposure during pregnancy is minimized (1"The Pink Sheet" Aug. 22, 2005, p. 14). Implementation of iPLEDGE sparked frequent complaints to the Center for Drug Evaluation and Research Ombudsman's office last year, causing the program's effectiveness to be questioned (2"The Pink Sheet" March 5, 2007 p. 9)...

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