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# 1st Cycle NDA Approvals Fall in 2024: CDER
- URL: https://www.fdaweb.com/1st-cycle-nda-approvals-fall-in-2024-cder/
- Published: 2025-01-08T12:00:00.000Z
- Updated: 2026-09-14T14:50:24.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158452

First-cycle NDA approvals fell in 2024 to 74% (37 of the 50 novel drugs approved) from 84% (46 of the 55 novel approvals) in 2023, according to CDER’s [annual new drug approvals report](https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2024?ref=fdaweb.com). In contrast, CDER approved 28 of the 37 (76%) novel drugs on the first cycle in 2022.

FDA likes to maintain a high rate of first-cycle approvals because it “partly reflects the extent to which CDER staff provide clarity to drug developers on the necessary study design elements and other data needed in the drug application to support a full and comprehensive drug assessment,” it has said in the past. If not approved on the first cycle, sponsors need to subsequently resubmit the application with additional information, starting another review cycle that may lead to the drug’s approval.

Regarding user fee goal performance, the report says that in 2024 CDER met or exceeded its Prescription Drug User Fee Act goal date for 47 of the 50 (94%) drug approvals. In 2023, the Center met its user fee goal dates for 49 of the 55 (89%) novel products approved. The agency had previously said that a number of novel drug approvals in 2023 were delayed due to COVID-19-related foreign travel restrictions, which prevented onsite inspections within the user fee review timeline.

The U.S. continues to lead the world in obtaining approvals before they get the green light in other countries, according to the report. In 2024, CDER says 34 of the 50 (68%) novel drugs approved were approved in the U.S. before being approved in other countries. In 2023, 35 of the 55 (64%) novel drugs were first approved in the U.S.

Additionally, expedited programs continue to be popular with sponsors electing to use them last year in 33 of the 50 (66%) new therapies approved. These include a fast track designation, breakthrough therapy designation, priority review designation, or accelerated approval, the agency says. In 2023, 36 of the 55 (65%) approvals relied on an expedited program.