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# NDA/BLA Approval Metrics Take a Hit in 2022
- URL: https://www.fdaweb.com/nda-bla-approval-metrics-take-a-hit-in-2022/
- Published: 2023-01-10T12:00:00.000Z
- Updated: 2026-09-14T18:11:14.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153511

While drug and biologic approval totals were precipitously lower last year (see [*CDER Dismisses 26% Drop in 2022 Drug Approvals*](https://www.fdaweb.com/cder-dismisses-26-drop-in-2022-drug-approvals/)), the Center’s “first cycle approval” rate for NDAs/BLAs approved in 2022 also fell from 86% in 2021 to 76% (28 of the 37 novel approvals) in 2022, according to a just-released CDER new therapy [approval report](https://www.fda.gov/media/164429/download?ref=fdaweb.com). It also notes that 68% of novel approvals (25 of the 37 drugs approved) were approved in the U.S. before being approved in other countries, a decline from 76% of such drugs approved first in the U.S. in 2021\. And, the report says, 65% of drugs approved in 2022 used an expedited program — fast track designation, breakthrough therapy designation, priority review designation, and accelerated approval — again, substantially lower than the 74% of approvals using an expedited program in 2021.

Additionally, accelerated approvals dropped off considerably in 2022\. In 2021, CDER approved 14 or 28% of all drugs under accelerated approval, but in 2022 only six novel drugs (16%) were approved under this program. The accelerated approval program has seen increased scrutiny by the agency, including a number of advisory committee meetings that were held to discuss whether specific drugs should be withdrawn after a confirmatory trial failed to confirm a clinical benefit.

Meanwhile, FDA reforms included in last month’s omnibus spending bill included highly anticipated accelerated-approval modifications that may make the program less strategically attractive, such as giving the agency authority to require a confirmatory study to be underway prior to approval, or within a specified time period after approval. The law also spells out “expedited procedures” FDA can take to force an accelerated-approval product from the market when a drug sponsor’s confirmatory data fail to demonstrate a clinical benefit. Another accelerated approval modification requires drug sponsors to submit twice per year a progress report on any required study, including progress toward enrollment targets and milestones.