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S. 373: BENEFIT Act of 2021

We don’t have a summary available yet.

The summary below was written by the Congressional Research Service, which is a nonpartisan division of the Library of Congress, and was published on Feb 23, 2021.

Better Empowerment Now to Enhance Framework and Improve Treatments Act of 2021 or the BENEFIT Act of 2021

This bill requires the Food and Drug Administration (FDA) to consider relevant patient-focused drug development data, such as data from patient preference studies and patient-reported outcome data, in the risk-benefit assessment framework used in the process for approving new drugs.

After a new drug application has been approved, the FDA's public statement about how it used patient experience data shall include a description of how such data was considered in the risk-benefit assessment framework.