In July 2025, the FDA published a second large batch of over 200 Complete Response Letters (CRLs), which are formal notifications sent to drug sponsors when approval for a new drug application or biologics license is denied.12
This move is part of the agency's push towards 'radical transparency,' intending to make CRLs routinely and promptly available to the public in real time, rather than keeping them confidential or only releasing them selectively.345
The newly released CRLs mainly cover drug applications submitted between 2020 and 2024 that have since been approved, though some may predate 2020; additional CRLs—including for unapproved or pending applications—may also be released in the future.13
Going forward, the FDA announced that it will publish CRLs in real time, immediately after they are issued to sponsors, and release all CRLs associated with any drug upon its approval.35
This policy shift raises legal and business concerns for life sciences companies, particularly regarding confidentiality, trade secrets, and SEC disclosure obligations—potentially affecting securities litigation risks.14
Publication of the letters is part of a broader FDA data modernization and transparency initiative, aligned with a May 2025 executive order to enhance scientific data sharing across agencies.5
Sources:
1. https://datamatters.sidley.com/2025/07/14/fda-release-of-complete-response-letters-raises-confidentiality-disclosure-questions-but-offers-insights-for-development/
2. https://firstwordpharma.com/story/5994854
3. https://www.thepharmaletter.com/pharmaceutical/fda-plans-real-time-release-of-crls
4. https://www.skadden.com/insights/publications/2025/08/fda-pivots-on-publishing-complete-response-letters
5. https://medcitynews.com/2025/09/fda-complete-response-letter-drug-rejection-public-record-martin-makary/