Just FWIW, The FDA has good BTD info starting at .... (this may have been posted before)
http://www.fda.gov/RegulatoryInformatio … 329491.htm
...... which is their BTD fact sheet. In the FAQ area, there's this .....
2) What is breakthrough therapy designation?
Breakthrough therapy designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. The criteria for breakthrough therapy designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy. A breakthrough therapy designation conveys all of the fast track program features (see below for more details on fast track designation), as well as more intensive FDA guidance on an efficient drug development program. The FDA also has an organizational commitment to involve senior management in such guidance. Section 902 of FDASIA requires the following actions, as appropriate:
- holding meetings with the sponsor and the review team throughout the development of the drug
-- providing timely advice to, and interactive communication with, the sponsor regarding the development of the drug to ensure that the development program to gather the nonclinical and clinical data necessary for approval is as efficient as practicable
- taking steps to ensure that the design of the clinical trials is as efficient as practicable, when scientifically appropriate, such as by minimizing the number of patients exposed to a potentially less efficacious treatment
- assigning a cross-disciplinary project lead for the FDA review team to facilitate an efficient review of the development program and to serve as a scientific liaison between the cross-discipline members of the review team (i.e., clinical, pharmacology-toxicology, chemistry, manufacturing and control (CMC), compliance) for coordinated internal interactions and communications with the sponsor through the review division’s Regulatory Health Project Manager
- involving senior managers and experienced review staff, as appropriate, in a collaborative, cross-disciplinary review
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They even provide a chart, updated biweekly, regarding the numbers of BTD apps processed. Here's the most recent chart:
http://www.fda.gov/downloads/Regulatory … 354844.pdf
FY2013 CDER Breakthrough Requests October 1, 2012 -May 31, 2013
Total Requests Received 51
Total Requests Granted 19
Total Requests Denied 14
Performance1 100%
Note: Table last updated COB May 31, 2013, and includes requests received but pending a decision at the time of update. As of June 1, 2013, this table will be updated bi-weekly.
1 Percent where action was taken within 60 days of receipt of the request for breakthrough therapy designation. |
