The need for speed and safety: A primer on the FDA's drug approval pathways The Food and Drug Administration’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 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 — and how those pathways could change in the future. Get the report
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