FDA Announces Real-Time Release of Complete Response Letters, Posts Previously Unpublished Batch of 89

https://www.fda.gov/news-events/press-announcements/fda-announces-real-time-release-complete-response-letters-posts-previously-unpublished-batch-89?utm_medium=email&utm_source=govdelivery On Thursday, the FDA announced that it will release future complete response letters (CRLs) promptly after they are issued to sponsors. The agency also released 89 previously unpublished CRLs issued from 2024 to the present associated with pending or withdrawn applications. Each of these CRLs detail specific safety and effectiveness deficiencies identified by the FDA as preventing the application from receiving approval. Going forward, the agency will promptly release newly issued CRLs, and when approving applications will release all CRLs associated with that application. The FDA will also publish batches of previously issued CRLs associated with withdrawn or abandoned applications. All CRLs will be redacted to remove confidential commercial information, trade secrets, and personal private information, but will contain company names.