FDA Issues Draft Guidance for Industry, Considerations for Rescinding Breakthrough Therapy Designation

Draft Guidance

June 24, 2022

The U.S. Food and Drug Administration issued a draft guidance for industry titled Considerations for Rescinding Breakthrough Therapy Designation. This draft guidance explains how FDA may consider whether to rescind a breakthrough therapy designation (BTD) during its evaluation of a drug development program.

FDA’s BTD program facilitates and expedites the development of drugs that receive BTD designation. The agency has authority to grant BTD only to drugs that meet the legal criteria, and periodically assesses whether designated products continue to meet the criteria for BTD. The information supporting FDA’s granting of BTD for a particular drug or biologics may change over time. Some drugs or biologics that appear promising in early development, for example, may not be shown to be safe or effective in later trials. If the BTD designation is no longer supported by subsequent data, FDA may rescind the designation.

For information on the draft guidance and how to comment, please see the Federal Register Notice.

Download Draft Guidance

Read the Federal Register Notice

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