- Considerations for Rescinding Breakthrough Therapy Designation🔍
- FDA outlines rescission of Breakthrough Therapy Designation🔍
- Frequently Asked Questions🔍
- FDA Unveils Considerations for Rescinding Breakthrough Therapy ...🔍
- Manual of Policies and Procedures 6025.6 Rev. 1🔍
- Rescinding Breakthrough Therapy Designation – Guidance ...🔍
- Through with Breakthrough? FDA's New Draft Guidance Reflects an ...🔍
- Optimizing the Breakthrough Therapy Designation🔍
FDA outlines rescission of Breakthrough Therapy 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).
FDA outlines rescission of Breakthrough Therapy Designation
The US Food and Drug Administration (FDA) issued the draft guidance “Considerations for Rescinding Breakthrough Therapy Designation,” which outlines how FDA ...
Frequently Asked Questions: Breakthrough Therapies - FDA
Breakthrough therapy designation is intended to expedite the development and review of drugs for serious or life-threatening conditions.
FDA Unveils Considerations for Rescinding Breakthrough Therapy ...
The guidance explains how the FDA may rescind a drug or biologic candidate's breakthrough therapy designation during its development.
breakthrough therapy designation, and outlines at a high level, the features of ... breakthrough therapy designation and an Intent to Rescind ...
The following outlines the procedures for rescinding a breakthrough therapy designation: o The review team identifies that a breakthrough ...
Rescinding Breakthrough Therapy Designation – Guidance ...
Rescinding Breakthrough Therapy Designation – Guidance Provides FDA's Thinking ... The Agency lists the following general considerations for ...
Through with Breakthrough? FDA's New Draft Guidance Reflects an ...
Breakthrough Therapy Designation (BTD) was created in 2012 as part of the FDA Safety & Innovation Act (FDASIA). Section 506 of the Food, Drug, & ...
otherwise specified. 3 We update guidances periodically. For the most recent version of a guidance, check the FDA guidance web page at ...
FDA Unveils Considerations for Rescinding Breakthrough Therapy ...
What is breakthrough therapy designation (BTD)?. BTD is an FDA expedited drug development program under the Federal Food, Drug, and Cosmetic Act ...
Optimizing the Breakthrough Therapy Designation
For cross-discipline meetings in BTD drug development to be productive, it may be helpful to outline the role of both sponsors and the FDA in identifying when ...
Decisions on Non-oncology Breakthrough Therapy Designation ...
We reviewed Center for Drug Evaluation and Research (CDER) decisions to grant or deny breakthrough therapy designation requests for non-oncology drugs or ...
SOPP 8212: Management of Breakthrough Therapy-Designated ...
therapy designation, and outlines at a high level, the features of a breakthrough ... Rescind Breakthrough Therapy Designation letter will ...
Considerations for Rescinding Breakthrough Therapy Designation ...
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Considerations ...
Breakthrough Therapy Designation | Health Affairs
What's in the law? ... The FDA may also rescind the designation if further evidence reveals that the drug no longer meets the qualifying criteria.
A change of pace: Accelerated Approval reform passed by U.S. ...
Drugs that receive FTD may be granted more frequent meetings and written communication with FDA, and rolling review. However, FTD may be rescinded if the agency ...
Developing Standards for Breakthrough Therapy Designation in ...
Using this regulatory pathway, once a promising new drug candidate is designated as a “Breakthrough Therapy”, the FDA and sponsor would collaborate to determine ...
how FDA can rescind breakthrough designation - Lexology
the designated drug no longer demonstrates substantial improvement over a new available therapy, e.g., where another drug obtains traditional ...
Expedited Programs for Serious Conditions – Drugs and Biologics
If a sponsor has not requested breakthrough therapy designation, FDA may suggest that the sponsor consider submitting a request if: (1) after reviewing ...
Premarket Pivotal Trial End Points and Postmarketing Requirements ...
Results From 2013 to 2023, the FDA approved 157 original indications with breakthrough therapy designation. Of these, 52 (33%) were granted ...