Decoding the FDA’s Accelerated Approval Program: Evaluating Advancements and Challenges
by Anastasia E. Boutris, 2026 PharmD Candidate, Noemi Cervera Evangelista, 2026 PharmD Candidate, Christina D. Choi, 2026 PharmD Candidate, Maura C. Keenan, 2026 PharmD Candidate, Maddie G. Lechmaier, 2026 PharmD Candidate, Kristin Busse, PharmD, BCP
The U.S. Food and Drug Administration (FDA)’s Accelerated Approval Program was created to allow for earlier approval of drugs that treat serious conditions and fill an unmet medical need based on a surrogate endpoint. These medications are available to patients quicker than drugs approved through the traditional approval program. While these medications reach their demographic faster, there is still the potential for a withdrawal from the market after confirmatory trials are completed. Gaps in pharmacological treatment can leave patients lacking the care they need. Having a reliable approval program that successfully converts medications from accelerated approval to traditional approval is vital to this expedited program. This article aims to comprehensively review both successes and shortcomings of the FDA’s Accelerated Approval Program to evaluate the value of the program and to highlight potential areas for improvement.
Keywords: FDA, Accelerated Approval, Traditional Approval Process
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2024 July/August Table of Contents
The U.S. Food and Drug Administration (FDA)’s Accelerated Approval Program was created to allow for earlier approval of drugs that treat serious conditions and fill an unmet medical need based on a surrogate endpoint. These medications are available to patients quicker than drugs approved through the traditional approval program. While these medications reach their demographic faster, there is still the potential for a withdrawal from the market after confirmatory trials are completed. Gaps in pharmacological treatment can leave patients lacking the care they need. Having a reliable approval program that successfully converts medications from accelerated approval to traditional approval is vital to this expedited program. This article aims to comprehensively review both successes and shortcomings of the FDA’s Accelerated Approval Program to evaluate the value of the program and to highlight potential areas for improvement.
Keywords: FDA, Accelerated Approval, Traditional Approval Process
Download PDF
2024 July/August Table of Contents