complete response letter (CRL)
the FDA's formal notice that it will not approve a drug application in its current form, listing the deficiencies a resubmission must address.
"the FDA rejected the drug" almost always means a CRL. it is a document with specific contents, and what it asked for is the test every resubmission should be read against.
what it is
When the FDA completes its review and decides against approval, it issues a complete response letter describing what would be needed — new trials, new analyses, manufacturing fixes. The letter itself is typically not published by the FDA at the time (companies characterize it), which is why careful coverage distinguishes what the agency asked for from what the sponsor says it asked for.
the live psychiatric example
MDMA-assisted therapy received a CRL in August 2024 after an advisory committee voted 9–2 that effectiveness was not established; the FDA's request, per the sponsor's own disclosure, included a new efficacy trial. The 2026 resubmission — per the one primary statement available — arrives without one. Reading the resubmission against the CRL's ask is the whole analysis; our status page does exactly that.
somewhere to put it
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questions
is a CRL final?
No — sponsors can resubmit with new evidence, meet with the agency, or appeal. Many approved drugs took a CRL on the way. It is a closed door with instructions on it, not a locked one.
more from the glossary
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