About FDA

Office of Generic Drugs

OGD Organizational Chart

The Office of Generic Drugs (OGD) is responsible for providing regulatory oversight to expedite the availability of safe, effective, and high-quality generic drugs to patients.  We also provide guidance to regulated industry on a wide variety of clinical, scientific, and regulatory matters relating to generic drugs. We are committed to maintain the public’s confidence in an Agency that continues to meet the ever-changing needs of public health.

OGD Mission:

To ensure through a scientific and regulatory process, that generic drugs are safe and effective for the American public.

Generic Drug User Fee Amendments of 2012  (GDUFA)

OGD is the interface for abbreviated new drug (ANDA) firms to interact with the Generic Drug Program. GDUFA is designed to speed access to safe and effective generic drugs to the public and reduce costs to industry.

GDUFA Regulatory Science

FDA agreed in the GDUFA Commitment Letter to immediately begin work on the FY 2013 Regulatory Science Plan and to consult with industry and the public to create an annual list of regulatory science initiatives specific to research on generic drugs.


Related Resources


Contact FDA

301-595-1147 Fax
Office of Generic Drugs

Immediate Office

10903 New Hampshire Avenue

Silver Spring, MD 20993

Page Last Updated: 06/23/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English