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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.

 

News and Anouncements

 

Meetings

 

Regulatory Science

 

Mission

Make safe and effective generic drugs available to the American public by ensuring that OGD standards (as reflected in reviews, guidance and communications to sponsors and the public) continue to be based on the best currently available science and the results of regulatory science research.

Vision

  • OGD Science recognized across FDA as the leader and definer of the science of equivalence.
  • Combine computational, in vitro and in vivo approaches to produce innovative regulatory science results.
  • Build a collaborative innovative pre-ANDA process for complex products that allows CDER to meet GDUFA goals on complex generic products.

Core Values

  • Scientific Excellence
  • Creativity and Innovation
  • Operational Excellence
  • Courage
  • Stewardship

Links

 

Archives

 

 

Contact FDA

240-276-9310
240-276-9327 Fax
Office of Generic Drugs

Immediate Office

7500 Standish Place

Rockville, MD 20855