FDA Begins Publishing Complete Response Letters for Ongoing Drug Applications in Real Time

The FDA has begun releasing complete response letters (CRLs) to the public in real time as they are issued to drug sponsors, marking the first time CRLs for ongoing and not-yet-approved applications are disclosed.4 5

Historically, these letters remained confidential unless companies voluntarily released details, which they often did incompletely—sponsors omitted 85% of FDA concerns in their public announcements according to a 2015 study.1 2

The new transparency initiative includes the release of 89 new CRLs for pending or withdrawn applications, in addition to more than 200 CRLs previously published for approved applications between 2020 and 2024.3 4 5

CRLs detail specific reasons an application cannot be approved, often citing safety and efficacy issues, manufacturing problems, or bioequivalence concerns, with recommendations for remediation included.1 2 4

The move is intended to help developers avoid common mistakes, facilitate more efficient drug development, provide greater context for investors and clinicians, and restore public trust in the FDA review process.3 4 5

All published CRLs are redacted to remove confidential commercial information, trade secrets, and personal data, but company names are disclosed. The documents are available via openFDA.3 4

This policy shift aligns with Executive Order No. 14303, which directs agencies to release scientific and technological data relevant to public policy and important private sector decisions.4

The FDA plans to continue releasing additional historic CRLs from past applications to further enhance regulatory transparency.1 4