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# 1st Generic Drug Quarterly Performance Report
- URL: https://www.fdaweb.com/1st-generic-drug-quarterly-performance-report/
- Published: 2018-03-15T12:00:00.000Z
- Updated: 2026-09-14T23:53:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140989

FDA has issued the first report of generic drug quarterly metrics required under the GDUFA 2 user fee amendments. The [report](https://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/GenericDrugs/ucm600678.htm?ref=fdaweb.com) shows that at the end of the FY 2018 first quarter, there were 2,055 ANDAs awaiting FDA action. The mean full approval time was 41.7 months and the mean tentative approval time was 32.92 months.