FDA Extends Comment Period for Draft Guidance on Accelerated Approval of Drugs and Biologics
January 18, 2025
January 18, 2025
WASHINGTON, Jan. 18 (TNSFR) -- The Food and Drug Administration (FDA) has announced an extension to the comment period for its draft guidance titled "Expedited Program for Serious Conditions--Accelerated Approval of Drugs and Biologics."
Initially published on December 6, 2024, the FDA has responded to requests for more time to review and comment on the draft guidance by extending the submission deadline by 30 days. This extension, which will now close on March 6, 2025, a . . .
Initially published on December 6, 2024, the FDA has responded to requests for more time to review and comment on the draft guidance by extending the submission deadline by 30 days. This extension, which will now close on March 6, 2025, a . . .