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U.S. Department of Health and Human Services

About FDA

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Office of Generic Drugs


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.

 

GDUFA

OGD is the interface for abbreviated new drug (ANDA) firms to interact with the Generic Drug Program.

 

Regulatory Science

 

 

News and Announcements

 

Meetings

 

 

Contact FDA

240-402-7920
301-595-1147 Fax
Office of Generic Drugs

Immediate Office

10903 New Hampshire Avenue

Silver Spring, MD 20993