FDA Mandates Changes to iPLEDGE Program for Isotretinoin

Source link : https://www.newshealth.biz/health-news/fda-mandates-changes-to-ipledge-program-for-isotretinoin/

In a letter dated Nov. 30, 2023, the Food and Drug Administration informed isotretinoin manufacturers that they have 6 months to make five changes to existing iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) requirements for the acne drug isotretinoin. The development follows a March 2023 joint meeting of the FDA’s Drug Safety and Risk Management […]

Author : News Health

Publish date : 2023-12-06 21:30:40

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