FDA Issues Draft Guidance for Industry, Considerations for Rescinding Breakthrough Therapy Designation


The U.S. Food and Drug Administration issued a draft guidance for industry titled Considerations for Rescinding Breakthrough Therapy Designation.
This draft guidance explains how FDA may consider whether to rescind a Breakthrough Therapy Designation (BTD) during its evaluation of a drug development program.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

 If the BTD designation is no longer supported by subsequent data, FDA may rescind the designation.

Considerations for Rescinding Breakthrough Therapy Designation.

This guidance explains how, during its evaluation of a drug development program, FDA may consider whether to rescind a breakthrough therapy designation (BTD) that has been granted. The guidance is consistent with, and supplements, the information on BTD contained in the guidance for industry entitled “Expedited Programs for Serious Conditions—Drugs and Biologics” (May 2014) and in other BTD policies and procedures of the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) to expedite the development and review of a breakthrough therapy.


DATES: Submit either electronic

Submit either electronic or written comments on the draft guidance by August 23, 2022 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.

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