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GAO: Generic Drug User Fees: Application Review Times Declined, but FDA Should Develop a Plan for Administering Its Unobligated User Fees

June 1, 2017

Pursuit's Take

Nearly 90% of the prescription drugs dispensed in the United States are generics. The Food and Drug Administration must approve these drugs before they are marketed.

In 2012, a law allowed FDA to collect fees from drug manufacturers to support the review process. FDA committed to improving its process and meeting specific performance goals such as decreasing review times.

GAO found that FDA’s reliance on user fees increased and that it surpassed many of its performance goals.

Read the full report Artboard 1

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