Issue Date: June 24, 2022
Issued by: Center for Drug Evaluation and Research
Topic(s): Administrative / Procedural
Status: Draft
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). This guidance is consistent with, and supplements, the information on BTD contained in the guidance for industry Expedited Programs for Serious Conditions––Drugs and Biologics (May 2014) and other BTD policies and procedures of the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).
Download the Guidance Document
