By Aging Research, Published March 10, 2025
The Alliance for Aging Research, the Partnership to Fight Chronic Disease (PFCD), and the Global Alzheimer’s Platform Foundation (GAP) submitted comments today on both of the recently issued draft guidances on accelerated approval—Expedited Programs for Serious Conditions—Accelerated Approval of Drugs and Biologics (hereafter the “Programmatic Guidance”) and Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway (hereafter the “Confirmatory Trial Guidance”).
The comments offer insight to underscore features of the guidance that the groups collectively found particularly informative and helpful, as well as a few specific comments on ways in which the guidances could be further refined as they are finalized.
Collectively, the Alliance, PFCD and GAP explain that the accelerated approval pathway is a critical tool to enable FDA to expedite availability of drugs and biologics to address unmet medical need in the treatment of a serious or life-threatening diseases or conditions.