On July 10, 2025, the FDA released over 200 Complete Response Letters (CRLs) concerning drug and biological product applications submitted between 2020 and 2024. This initiative aims to enhance transparency and provide insights into FDA decisions and common application flaws. CRLs are issued when the FDA cannot approve an application, citing issues such as safety, efficacy, or manufacturing defects. Historically, drug developers struggled with unclear FDA communications, often neglecting to disclose key concerns to the public.
FDA Commissioner Marty McCurry highlighted that earlier, sponsors downplayed 85% of the FDA’s concerns about non-approvals. The public can now access CRLs via OpenFDA, promoting greater understanding within the industry and preventing repeated mistakes. The FDA plans to continue publishing additional CRLs and researching ways to improve transparency.
The FDA’s mission includes safeguarding public health by regulating drugs, biological products, food, and other consumer goods.
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