The FDA accelerated drug approval program: benefits and limitations

24 September 2021

By Dr Nicola Davies

The aim of the US Food and Drug Administration’s Accelerated Approval Program (AAP) is to expedite the development of new therapies that address an unmet need in the treatment of serious diseases.1 However, recent controversies regarding AAP drugs have brought the program under severe scrutiny. We discuss the pros and cons of the program and how they impact its future.

What are the benefits of the AAP?

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