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# OGD Reports Record Generic Approvals Last Year
- URL: https://www.fdaweb.com/ogd-reports-record-generic-approvals-last-year/
- Published: 2017-02-24T12:00:00.000Z
- Updated: 2026-09-14T22:08:30.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138067

Last year, CDER’s [Office of Generic Drugs (OGD)](http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm119100.htm?ref=fdaweb.com) approved the highest number of ANDAs in the history of the generic drug program – more than 800 submissions (including full and tentative approvals). Last year’s performance eclipsed 2015’s previous record of 726 ANDAs.

In a new [blog posting](https://blogs.fda.gov/fdavoice/index.php/2017/02/2016-a-record-setting-year-for-generic-drugs/?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery), OGD director **Kathleen Uhl** attributed the record performance to resources provided under the [Generic Drug User Fee Amendments (GDUFA)](http://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/default.htm?ref=fdaweb.com) of 2012\. “With the assistance of many other offices throughout FDA, OGD is on track to meet, or has already met, all of our GDUFA commitments,” Uhl said. “In addition to increased approvals and tentative approvals, FDA improved communications processes to alert industry to deficiencies in their applications, which reduces the number of review cycles and supports faster approvals.”

  
OGD is also making a significant effort to spur generic drug development. “For example, [GDUFA Regulatory Science priorities](http://www.fda.gov/forindustry/userfees/genericdruguserfees/ucm370952.htm?ref=fdaweb.com) contribute valuable research to generic drug development,” Uhl said. “Our efforts are geared to helping the generic drug industry develop validated scientific methods for demonstrating bioequivalence and assuring therapeutic equivalence to the brand-name counterpart. We are translating the results of these scientific efforts into generic drug product development via [recommendations](http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm075207.htm?ref=fdaweb.com) for specific drug products, which assist the generic drug industry during product development.”