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Marty Makary: FDA Has Published More than 200 Complete Response Letters
Jul 11, 2025, 15:18

Marty Makary: FDA Has Published More than 200 Complete Response Letters

Marty Makary, 27th Commissioner of the U.S. FDA, shared a post on LinkedIn:

“Today, we’re delivering on our promise of radical transparency. The FDA just published 200+ complete response letters – the actual decision letters we send to drug companies when applications need more work. No more guessing games. Developers, investors, and patients deserve to see how we make decisions.

For decades, the same regulatory mistakes have been repeated because lessons from FDA rejections stayed hidden. Today, we published our complete response letters so the entire industry can learn from each other’s missteps. Predictability accelerates cures.”

FDA shared this post, adding:

“Today, the FDA published more than 200 decision letters, known as complete response letters or CRLs. Important update!”

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Marty Makary: FDA Has Published More than 200 Complete Response Letters

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