Evidence topic
These reviews answer questions whose evidence is a regulatory record rather than a literature: what an agency action did, what it did not do, and what the interval between the two permits. The distinction matters commercially, because every one of these events has been reported somewhere as a clearance.
Each piece states the action, its date, and the position it leaves a molecule in; where this index has verified no further action, the review says so and gives the date the check was made.
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What is PT-141's actual United States posture, and what does its approval cover?
PT-141 is bremelanotide, approved in June 2019 under NDA 210557 for premenopausal women with acquired, generalized hypoactive sexual desire disorder and for nothing else; the label excludes men and postmenopausal women, and no compounded or research-use vial is that product.
Why did CJC-1295 leave Category 2 in September 2024, and what is its status now?
Its nominators withdrew the nomination, so the FDA removed it from the prohibition category without adding it to Category 1; the compound sits on no list, and no lawful compounding route exists.
Why was DSIP the only peptide the July 2026 committee refused to recommend?
The panel voted against listing on a reported 6–7 with one abstention, and the record it was reading contains no identified gene, precursor protein, or receptor after nearly fifty years, alongside a human literature of a few small studies whose most recent entry dates from 1992.
A review argues from the ledger; the ledger itself is published as reference tables, and every molecule’s dated posture is in the molecule index. Terms of art are defined in the glossary.