STAT

Involved in

No claim in the record names this entity as a participant yet.

Statements attributed to it

• FDA staff said their review of research found insufficient evidence to support semax’s use for the conditions in question.

  independent

• The FDA advisory panel recommended that compounding pharmacies be allowed to manufacture the peptides epitalon and semax, and recommended against manufacturing emideltide.

  independent

• On Friday, the panel voted 7-4 to add epitalon to the list for insomnia.

  independent

• Peptides have become increasingly popular in the United States, driven by endorsements from social media influencers.

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• The administration will publish its decision as a proposed rule and give the public the opportunity to comment.

  independent

• The vote on adding semax for migraines and neurological conditions was 8-5.

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• On Thursday, the panel voted 8-6 to add BPC-157 to the list for treating ulcerative colitis, to add KPV for wound healing and inflammatory conditions, and to add TB-500 for wound healing.

  independent

• Vociferous supporters of semax noted that there is more data on the drug because it is approved in Russia for clinical use.

  independent

• It is possible that Robert F. Kennedy Jr. or Kyle Diamantas could overrule career employees.

  independent

• Emideltide failed voting passage by a tally of 6-7.

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• The panel’s decision on Thursday recommended allowing pharmacies to make four other peptides.

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• The panel’s decision brings Robert F. Kennedy Jr. one step closer to his mission of making these unapproved compounds more available for Americans.

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• Panelists who voted yes said they did not have to consider the lack of robust clinical data.

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• The agency has no authority to require compounders to submit safety or efficacy data once a substance is added to the list.

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• The article has been updated to add the vote on semax.

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• The panel voted 7-5 to add MOTS-c to the list for obesity and osteoporosis.

  independent

• FDA staff told the panelists they recommended against giving compounders the green light due to a lack of clinical evidence demonstrating safety and efficacy.

  independent

• FDA experts repeatedly stressed that adding the peptides to the section 503A bulk drug substances list would be a dangerous experiment, with physicians flying blind as far as dosing data and best prescription practices.

  independent

• Several panelists wanted to satisfy their individual patients who have been clamoring for these substances.

  independent

• The fundamental question facing panelists was whether it is acceptable to let individuals take medicines of unclear safety or efficacy.

  independent

Voices are counted, never weighed. This is a record of what this entity has been recorded as saying — not a measure of whether it is right.

Published documents

• FDA advisory panel narrowly rejects compounding of one peptide, backs two others

Track record

1 document · 24 claims produced · 0 contradicted

Counts, not a rating. The model does not compute a reliability score — that would invent precision the evidence does not support. None of its claims were restatements; each was an independent assertion.

Origin: produced by ingest:api