About the Office of Generic Drugs
The Office of Generic Drugs (OGD) carefully reviews generic drug applications (known as abbreviated new drug applications or ANDAs) to ensure patients receive safe, effective and high-quality generic drugs. The additional funds, staff, and authorities provided by the Generic Drug User Fee Amendments of 2012 (GDUFA) have been essential in aiding OGD’s ability to speed the review process.
We are committed to upholding the public’s confidence in a program that continues to meet the ever-changing needs of public health.
Our Mission: OGD makes high quality, affordable medicines available to the public.
OGD’s responsibilities include:
- Leading review of abbreviated new drug applications (ANDAs) and ensuring generic drugs are safe and effective
- Serving as the main point of contact between abbreviated new drug application (ANDA) applicants and the FDA Generic Drug Program
- Providing guidance and regulatory oversight to industry on a wide variety of clinical, scientific, and regulatory matters relating to generic drugs
- Leading FDA’s fulfillment of GDUFA ANDA review commitments
- Conducting and administering research in support of the GDUFA Regulatory Science Plan
- First Generic Drug Approvals
Activities Report of the Generic Drug Program (FY 2017)
- OGD Annual Report for 2015
- Product-Specific Recommendations for Generic Drug Development (formerly BE Guidances)
- Guidances Related to Generic Drugs
- Federal Register Notices Related to Generic Drugs
- Recent Presentations
GDUFA Regulatory Science