REMS vs. Labeling-only Strategy For Teratogenic Drugs Goes Before Advisory Panel
This article was originally published in The Pink Sheet Daily
FDA Drug Safety and Risk Management Advisory Committee will weigh in on which factors are most important in FDA’s proposed framework on how to manage a drug’s potential to cause birth defects.
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A Risk Evaluation and Mitigation Strategy for Qsymia includes prescriber education about the risk of birth defects and limits dispensing to specially certified pharmacies
Industry also seems supportive of the idea, while Pew touts the power of the power of track-and-trace as a deterrent.
EMD Serono has been tracking Serostim packages since 2002; J&J is using Prezista 600 mg as a trial run for serialization.