The need for speed and safety: A primer on the FDA's drug approval pathways

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The need for speed and safety: A primer on the FDA's drug approval pathways
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Published: May 2022

At the heart of the Food and Drug Administration’s work on drugs are some deceptively simple questions: Does the medicine in question provide a benefit for patients that outweighs its risks? Will the medicine at least keep the disease from progressing? Can doctors and patients believe the FDA has made the right call in approving this drug?

The FDA's traditional approval process involves a series of rigorous clinical trials that can take as long as a decade to set up, oversee, and evaluate. The agency has become more flexible with this standard, especially in cases where medicines may help people facing fatal or debilitating diseases. Now, however, some of the ways the FDA speeds up the drug approval process, like accelerated approval and fast-track designations, are coming under increasing scrutiny. 

Our latest report unpacks the differences between the different ways the FDA approves drugs, like accelerated approvals, fast-track designations, and emergency use authorizations. . It touches on how we got here, where the agency is headed next, and what's at stake as those standards shift and change.

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