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Silver Spring, MD, USA – June 25, 2022: The FDA White Oak Campus, headquarters of the United States Food and Drug Administration, a federal agency of the Department of Health and Human Services (HHS). | Image Credit: © Tada Images – stock.adobe.com
Two months after saying it would embrace “radical transparency” by publishing complete response letters (CRLs) issued in response to drug approval applications, FDA said on Sept. 4, 2025 that it was furthering that policy by releasing future CRLs “promptly” after being issued to sponsors (1,2). The agency immediately released 89 previously unpublished CRLs, issued from 2024 to the present,…