FDA Issues Draft Guidance on Accelerated Approval Requirements
January 07, 2025
January 07, 2025
WASHINGTON, Jan. 7 (TNSFR) -- The Food and Drug Administration (FDA) has released a draft guidance titled "Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway." This document addresses the agency's interpretation of confirmatory trials mandated under the accelerated approval process for drugs.
These trials are critical for verifying the clinical benefits or effects of such drugs on irreversible morbidity or mortality. The . . .
These trials are critical for verifying the clinical benefits or effects of such drugs on irreversible morbidity or mortality. The . . .