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# All GDUFA Obligations Being Met: Uhl
- URL: https://www.fdaweb.com/all-gdufa-obligations-being-met-uhl/
- Published: 2016-02-25T12:00:00.000Z
- Updated: 2026-09-15T02:38:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134883

> CDER Office of Generic Drugs (OGD) director **Kathleen Uhl** says that OGD is meeting all of its obligation under the GDUFA commitment letter. In a 2/23 slide [presentation](http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM487832.pdf?ref=fdaweb.com) to the Generic Pharmaceutical Association annual meeting, she said that OGD is “going above and beyond the commitments” and building a modern, 21st century, generic drug program. The result of this work, she says, has been a significant and sustained increase in communications, actions, and approvals.  
>  
> The presentation says that actions and approvals/temporary approvals are all up, as is communications. For the first quarter of the current fiscal year, it says, there were 190 approvals, 48 tentative approvals, and 310 complete responses. December of 2015 saw the highest number of approvals and tentative approvals in one month, 99, she said. And calendar year 2015’s approvals and tentative approvals was the highest ever at more than 700.  
>  
> The presentation covered output and productivity, quality of ANDA submissions, an update on the pre-year 3 cohort, and opportunities for improvement and challenges.