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US FDA plans accelerated approval for drugs based on early data

U.S. Food and Drug Administration Commissioner Scott Gottlieb told the House Energy and Commerce Committee that the agency plans to approve drugs quickly based on early data showing benefit for a serious unmet medical need.

Gottlieb said the agency might require a post-market confirmatory study to validate the finding — similar to an accelerated approval approach.

In the hearing, Gottlieb told the committee that Congress has given the agency power under the Food and Drug Administration Safety and Innovation Act to grant accelerated approval based on intermediate clinical endpoints.

The FDA is also creating a proposal to reduce the time it takes to approve cancer drugs for additional types of tumors, allowing approval in a second indication based on a single-arm study. Gottlieb said the agency will issue guidance further clarifying the circumstances in which this is appropriate.