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# First-Cycle Drug Approvals Improve: Report
- URL: https://www.fdaweb.com/first-cycle-drug-approvals-improve-report/
- Published: 2024-01-08T12:00:00.000Z
- Updated: 2026-09-14T14:19:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156091

CDER “first-cycle” drug approvals in 2023 shot up to 84% (46 of 55 NDAs) from 76% (28 of 37 NDAs) in 2022, according to a[ just-released report ](https://www.fda.gov/media/175253/download?attachment&ref=fdaweb.com)entitled *Advancing Health Through Innovation:* New Drug Therapy Approvals 2023\. “This high percentage is in part reflective of 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,” the report says.

Of the 55 novel drugs approved last year, the report says 51% (28 NDAs) received orphan drug designations because they target rare diseases. This is slightly down from last year when 54% (20 of 37 NDAs) of the approvals were orphan drugs.

On the user fee front, 49 of the 55 (89%) NDAs approved last year met or exceeded goal dates for 49 of these approvals (89%). In comparison, CDER met or exceeded its goal dates for 36 of 37 the novel drugs approved (97%) in 2022\. The report also adds that a number of novel drug approvals in 2023 were delayed due to Covid-19 foreign inspection restrictions.