Expert comment: FDA to promptly publish issued CRLs to increase transparency

FDA has recently released a large number of redacted CRLs for both approved and unapproved New Drug Applications (NDAs) and Biologics License Applications (BLAs) through their database openFDA. In July more than 200 CRLs from 2020-2024 were published and in September a further 89 previous unpublished CRLs from 2024 were added.

This marks a shift from the FDA’s previous policy of not publishing CRLs for pending applications. While this change promotes greater transparency and may help drug developers bring medicines to market more efficiently by avoiding common pitfalls, it also carries significant implications for drug sponsors. 

Specifically, the public disclosure of a CRL for a pending application could affect investor relations and impact future funding opportunities.

Erik Hedner
Head of Regulatory Affairs & CMC