FDA panel approves compounding of four wellness peptides

FDA panel approves compounding of four wellness peptides

The FDA’s Pharmacy Compounding Advisory Committee in Silver Spring, Maryland, voted to add four experimental wellness peptides—BPC-157, KPV, TB-500 and MOTS-c—to the list of compounds that can be prepared by compounding pharmacies. The decision followed a series of meetings that the agency announced in July to review the possible reclassification of several peptides, according to WIRED. NPR reported that the committee was set to assess the safety of seven widely used injectable peptides, while CNN noted that the review would consider adding them to the 503A Bulks List.

Al Jazeera highlighted concerns about limited clinical evidence and potential conflicts of interest among panel members. ABC News said the committee voted 8-6 to place BPC-157 on the compounding list, and NBC News later reported the narrow approval of the four peptides despite objections from career scientists. Ars Technica summarized the outcome, noting that the recommendation to lift manufacturing limits was made despite the absence of human safety and efficacy data.

参与者

Food and Drug Administration (FDA) Mochi Health Myra Ahmad Hims & Hers Health Anant Vinjamoori Olympia Pharmaceuticals Joshua Fritzler RxConnexion Sapho Bio LegitScript Gerard Olson Amanecia Health Ann Czarnik Alliance for Pharmacy Compounding OnTop Labs Thomas Millman

地点

Silver Spring, Maryland, United States

文章

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1 篇总计
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ABC News - Breaking News, Latest News and Videos • 07月23日 18:38

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The future of peptides in the US is about to become clearer. Here’s what you should know
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Peptides get their regulatory closeup
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NPR • 07月22日 09:00

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