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The agency also published 89 previously unreleased complete response letters related to pending or withdrawn applications.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, said in a statement. “By embracing radical transparency — one of the guiding principles of this administration — we’re giving invaluable insights to help speed therapies and cures to market, providing complete context to investors and shareholders, and above all, restoring public trust.”
In line with current practices, all letters will be redacted to remove confidential information, such as trade secrets, but include company names.
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