Four key features influencing FDA review times of new drug applications (NDA)

According to a Government Accountability Office (GAO) report, the length of review of an NDA by the US Food and Drug Administration (FDA) is reflective of four features of the application.

Overall, the FDA must determine if a drug is safe and effective for use in the US, therefore, the company applying to market the drug must submit evidence for review. FDA’s target is to complete 90% of NDA reviews within specific time frames linked to key features of the application. Some drugs receive priority designation for expedited reviews, such as those which may show a significant improvement over currently available treatments.

A recent GAO report analysed 637 new drug applications submitted from 2014-2018, including biologic license applications (BLA), and found the FDA met its target.

Overall GAO found that four key features influenced initial NDA review times:

  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 or more of FDA’s three expedited pathways that can speed reviews of certain drugs for serious or life-threatening conditions, such as fast-track, breakthrough or accelerated approval pathways.

The FDA has 17 divisions that specialise in the review of specific groups of drug products, such as dermatology or haematology. The GAO report showed that differences in review times between divisions were largely dependent on the characteristics of the applications being reviewed. For example, 56% of the NDA reviews by the anti-infective division involved priority designation, compared to only 6% for dermatology and dental divisions. Most of the divisions’ average review times were similar, to within two weeks of each other, however, the haematology and oncology divisions reviewed applications approximately 3 weeks faster.

Overall, the GAO report deduced that application review times largely reflected the FDA goals. To access the full report, click here.