FDA advisory panel backs compounding of BPC-157, TB-500 and four more peptides
Panel members voted by narrow margins against the agency's own scientists, who cited absent human data and risks including cancer promotion and immune reactions.
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By Daniel Okafor · Regulatory Correspondent
Sep 28 21:29 ETSource: LAist
The wire
- 01In a two-day meeting, an FDA advisory panel recommended reclassifying six of seven peptides under review so US compounding pharmacies could prepare them: BPC-157, MOTS-c, KPV, TB-500, Epitalon and Semax.
- 02If the agency follows the vote, clinicians could prescribe compounds now sold only as unvetted 'research use only' products online; Emideltide, used for insomnia, was voted down.
- 03FDA is not bound by advisory committee recommendations though it usually follows them; agency scientists advised voting no, noting none of the seven has large, well-controlled human trials.
From the source
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