Expedited Program for Serious Conditions-Accelerated Approval of Drugs and Biologics; Draft Guidance for Industry; Extension of Comment Period
Published Date: 1/17/2025
Notice
Summary
The FDA is giving drug makers and the public more time to share their thoughts on new rules that speed up approval for important medicines treating serious illnesses. This extension means comments are now due by March 6, 2025, helping ensure everyone’s voice is heard before final decisions. If you’re involved in developing or using these drugs, this extra time could impact how quickly new treatments reach patients.
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