FDA Requires Multiple Reports On New Accutane Risk Management Program
Executive Summary
FDA is requiring manufacturers of the acne therapy isotretinoin (Roche's Accutane and generics) to submit multiple reports to the agency on the effectiveness of the product's new risk management program iPLEDGE
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iPLEDGE gets another committee review
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)...
iPLEDGE gets another committee review
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)...
Accutane iPLEDGE Program Tops CDER Ombudsman’s 2006 Complaint List
The most frequent complaint to the Center for Drug Evaluation & Research Ombudsman's office in 2006 concerned implementation of the iPLEDGE program, the office said in its annual report, issued Feb. 28