Teratogenic Drugs Pose Little Risk To Partners Of Male Patients, FDA Panel Says
There is little to no evidence that a teratogenic drug would pass from a man to his female partner at a high enough level to endanger a fetus, the Drug Safety and Risk Management Advisory Committee tells FDA.
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FDA Plans To Improve REMS Effectiveness With Guidance On Goals And Metrics
The agency cited the forthcoming guidance in response to an HHS Inspector General report that questions the effectiveness of the risk management program.
Contraceptive Data Repository For Teratogenic Drug Patients Urged By FDA Panel
An updatable web-based repository of information on contraceptives would remedy the shortcomings of the current system, where information differs across drugs and is only as current as labeling, several members of the Drug Safety and Risk Management Advisory Committee note during a meeting on teratogenic risk management.
To REMS Or Not To REMS? Erivedge Shows Division At FDA Over Oncology Risk Management
The review division and CDER senior staff supported approval of Genentech’s highly teratogenic, basal cell carcinoma treatment vismodegib without a Risk Evaluation and Mitigation Strategy, but the Division of Risk Management believed a communications plan should be carried out under a REMS for the first-in-class Hedgehog pathway inhibitor.