Generally speaking, no, only documents related to approved drugs are published by FDA (most readily available at the Drugs@FDA website*). Complete Response Letter (CRLs), or rejections, are not publicly available for drugs that have not been approved, and one may only gain knowledge of those through public announcements (i.e. press releases from public companies, as these are financially material events). However, drugs that were initially rejected but are later approved do have those documents become public as a part of the review materials, though this is often significantly after the fact.
*Note that not all materials are available by FDA - these generally consist of FDA review summaries and are redacted (heavily in the case of CMC sections in particular), and only apply to the initial approval and efficacy supplement approvals for new indications, mostly. Timing of approvals may be inconsistent, and FOI requests may be needed to gain additional information, but those may take even longer.
Some other jurisdictions (i.e. Europe via EMA) do make some information available regarding rejected and/or withdrawn drug applications, so in case the drug of interest was submitted there it can be worth a look.
This is a continually hot topic - many have requested that such information be made public, although FDA is somewhat limited as CRLs are not final decisions, legally speaking, and are subject to resubmission - so investigational confidentiality limitations apply. There has been work to gain more transparency, although it will likely be a long road.
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Jonathan Amaya-Hodges
Director, Technical Services
Sharon MA
United States
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Original Message:
Sent: 04-Jan-2023 10:18
From: Stephanie Markey
Subject: Are rejected NDAs made public by the FDA?
Are rejected NDAs made public by the FDA?
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Stephanie Markey
Associate Director
Key West FL
United States
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