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"FDA's New Accelerated Approval Draft Guidance"

The FDA’s latest draft guidance on accelerated approval for new drugs, “Expedited Program for Serious Conditions--Accelerated Approval of Drugs and Biologics,” is a game-changer for biopharmaceutical companies hoping to bring life-saving treatments to market. If you’re navigating the commercialization process for innovative therapies, particularly in the rare disease space, this evolving pathway demands your attention.

The accelerated approval (AA) program aims to fast-track the development and approval of breakthrough drugs for serious or life-threatening conditions with unmet medical needs, especially in rare diseases and oncology. The updated guidance offers unprecedented clarity on eligibility and evidentiary requirements and clinical endpoint expectations—empowering biopharma companies to expedite market entry for critical drugs.

Success, however, in this program hinges on strategic decision-making. Identifying appropriate endpoints; selecting the right FDA division (the Centers for Biologics Evaluation and Research for biologics, including cell and gene therapies [CGTs], or the Center for Drug Evaluation and Research for conventional pharmaceuticals); and understanding the critical quality attributes (CQAs) for your product are crucial to avoiding costly and time-consuming missteps.

To make informed decisions before submitting an AA request, it’s critical to have a roadmap in place. Download to learn more. 

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