(AGENPARL) – SILVER SPRING gio 23 giugno 2022
Submit Comments by 08/23/2022
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document’s docket number: FDA-2021-D-1152
- Docket Number:
- Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research
Oncology Center of Excellence
This guidance explains how, during its evaluation of a drugP1F P 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).