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.
To ensure through a scientific and regulatory process, that generic drugs are safe and effective for the American public.
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.
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.
- 2015 REdl: Generic Drugs Forum Presentation Slides
- 2014 GDUFA and You Conference Presentation Slides
- Office of Generic Drugs – Generic Pharmaceutical Association (GPhA) Board of Directors Quarterly Meetings
- Meetings between FDA and the International Pharmaceutical Excipients Council (IPEC)
- Activities Report of the Generic Drug Program (updated monthly)
- Product-Specific Recommendations (formerly BE guidances)
- Orange Book
- Federal Register Notices
- CDER Webinars