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FDA Complete Response Letters

A complete response letter is how FDA tells a company its application will not be approved as it stands. The letters say it in their own words: “we cannot approve this application in its present form.” FDA publishes them, and every one it has released is listed below with its full text.

New to these? What a complete response letter means, and what the company has to do next.

Source: FDA’s complete response letter transparency release, via openFDA. Only records FDA labels COMPLETE RESPONSE appear here — the release also carries tentative approvals and refusals to file, which are different actions. Letter text is machine-read from FDA’s PDFs, so spacing and spelling errors come from that process, and (b) (4) marks FDA’s own redactions.