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Becker's Healthcare September 5, 2025
The FDA said Sept. 4 it will release complete response letters, or product rejection letters, “promptly after they are issued” to manufacturers.
The agency also published 89 previously unreleased complete response letters related to pending or withdrawn applications. The letters cite the FDA’s safety and effectiveness concerns with each product.
“This is a milestone day for the agency,” FDA Commissioner Marty Makary, MD,...
