FDA resumes publishing pharma rejection letters, posting 14 new CRLs

The FDA announced on Friday that it has posted fourteen new complete response letters (CRLs) to pharmaceutical companies on its website.

This marks a return to the agency’s regular practice of making rejection letters publicly available after a brief suspension that was confirmed by the Department of Health and Human Services earlier in the week.

The pause had been attributed to concerns raised by industry groups, but the FDA said the new letters reflect ongoing reviews of pending submissions.

No details about the specific products or companies were disclosed in the release.