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FDA Drug Approval: Application Review Times Largely Reflect Agency Goals

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Report Type Reports and Testimonies
Report Date March 6, 2020
Release Date April 6, 2020
Report No. GAO-20-244
Summary:

Before a drug can be marketed in the United States, the FDA must determine it is safe and effective. The company or entity seeking to market the drug must submit evidence for review. FDA’s goal is to complete 90% of these reviews within deadlines that vary depending on the drug. Some drugs—ones that may provide significant improvement over what’s available—receive priority designations for expedited reviews.

We reviewed 637 new drug applications submitted from FY 2014-2018 and found the FDA met its goals. Differences in review times among FDA’s 17 divisions were largely driven by the characteristics of the applications being reviewed.

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