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# Office of Generic Drugs 2022 Highlights
- URL: https://www.fdaweb.com/office-of-generic-drugs-2022-highlights/
- Published: 2023-03-01T12:00:00.000Z
- Updated: 2026-09-14T18:17:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153874

The 2022 CDER Office of Generic Drugs (OGD) Annual Report outlines many highlights during the year, concurrent with the GDUFA 3 reauthorization. OGD approved or tentatively approved 914 ANDAs, participated in 108 pre-ANDA meeting requests, issued 257 product-specific guidances, issued 1,775 complete response letters detailing deficiencies before an ANDA could be approved, and published 31 new policy documents. In the [report](https://www.fda.gov/drugs/generic-drugs/office-generic-drugs-2022-annual-report?utm%5Fmedium=email&utm%5Fsource=govdelivery), OGD acting director **Susan Rosencrance** says the implementation of FDA’s commitments under GDUFA 3 is “bringing the program to yet another level. It will build on the successes of the GDUFA 1 and GDUFA 2 programs, with a focus on reducing the number of assessment cycles to advance earlier approvals and promote the timely availability of generic medicines.”

Highlights detailed in the report are:

- renewal of GDUFA;
- scientific research;
- international collaborations;
- regulatory science education;
- generic drug approvals;
- first generics;
- significant first generic approvals in 2022; and
- communicating with industry.