|
CDER
Response to Request for "Fast Track" Designation FY 2004
| |
| Fast
Track Requests |
87 |
60 days |
45 |
21 |
17 |
83 |
95.4 |
2 |
2 |
0 |
4 |
4.6 |
Number of Fast Track
request actions granted or denied: 70
Median Fast Track
request response time: 50 days
* These figures are for sponsor
requests for 'Fast Track' designation for a specific drug product and indication, which is
not the same as a product being granted Approval under Subpart H.
NDAs Approved under Subpart H
NDA Supplements Approved under
Subpart H
| Fast Track
programs are designed facilitate the development and expedite
the review of new drugs that are intended to treat serious or
life-threatening conditions and that demonstrate the potential
to address unmet medical needs. Fast Track emphasizes the
critical nature of close, early communication between the FDA
and sponsors. Procedures such as pre-IND and end-of-phase
1 meetings are convened as ways to improve the efficiency of
pre-clinical and clinical development. These meetings can
help FDA and sponsors reach early agreement on design of the
major clinical efficacy studies that will be needed to support
approval. Fast Track policies are
primarily designed to expedite drug development during the IND
stage, whereas Approval under Subpart H allows approval of an
NDA based on an effect on a surrogate endpoint along with
well-controlled post-marketing studies. Therefore, a drug
developed under Fast Track may also qualify for Approval under
Subpart H. |
Update quarterly through
9/30/04
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Date created: November 2, 2004 |
