
The Accelerated Approvals Process: Are Drugmakers Fulfilling Their Promises?
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Examining FDA's Accelerated Approval Process
This chapter explores the historical context and current challenges of the FDA's accelerated approval process, particularly during the AIDS epidemic. It highlights disparities in drug approval timelines, patient safety concerns, and the lack of regulatory follow-up studies, raising important questions about the balance between urgency and efficacy in treatment access.
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