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Regulatory Focus™ > News Articles > 2020 > 4 > FDA drug review times reflective of 4 key features, GAO finds

FDA drug review times reflective of 4 key features, GAO finds

Posted 06 April 2020 | By Zachary Brennan 

FDA drug review times reflective of 4 key features, GAO finds

The length of review of new drug applications (NDAs) by the US Food and Drug Administration’s (FDA) divisions is generally contingent on four features of the application, according to the Government Accountability Office’s (GAO) analysis of 637 original NDAs submitted from fiscal years 2014 through 2018.

Overall, GAO found that the four key features are:

1. Whether the NDA qualifies for a priority review, which is four months less than for an otherwise standard, 10-month review.

2. Whether the NDA is for a new molecular entity (not previously marketed or approved in the US), which adds two months to a review.

3. Whether the applicant submits a major amendment while the NDA is under review, which can extend a review by three months.

4. Whether the NDA qualifies for one of FDA’s expedited pathways (Fast Track, Breakthrough Therapy, Accelerated Approval) that can speed reviews of certain drugs for rare or serious conditions.

“However, controlling for the effects of these key NDA features, GAO found that most of the divisions’ average review times were similar to (within 2 weeks of) each other. In contrast, the hematology and oncology divisions reviewed applications a bit more rapidly—about 2 or 3 weeks faster,” the report says.

But without such controls in place, review times varies across divisions and GAO found the median time taken to complete an initial review of an NDA by the anti-infective division was about two months faster than the median time taken by the gastroenterology and inborn errors division.

The types of applications also differed across divisions. For instance, 4% of NDAs reviewed by the anesthesia, analgesia, and addiction division involved a new molecular entity, while 52% of the NDAs reviewed by the neurology division involved one. In addition, 6% of the NDAs reviewed by the dermatology and dental division had a priority review designation, while 56% of the NDAs reviewed by the anti-infective division had a priority review designation.

Last August, GAO also evaluated FDA’s reviews of generic drugs.

GAO Report

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