Who We Are:
The Office of Generic Drugs (OGD) ensures, through a scientific and regulatory process, that Americans receive safe, effective, and high-quality generic drugs. FDA-approved generic drugs account for about 90 percent of prescriptions filled in the United States. All approved generic drugs have the same high quality, strength, purity and stability as brand-name drugs. The generic manufacturing, packaging, and testing sites must pass the same quality standards as those of brand name drugs. OGD is comprised of an immediate office and four subordinate offices, totaling approximately 450 employees.
What We Do:
- Review applications for the approval of generic drugs (known as abbreviated new drug applications.
- Serve as the central point of contact between applicants and the FDA Generic Drug Program.
- Provide guidance and regulatory oversight to industry on a wide variety of clinical, scientific, and regulatory matters relating to generic drugs.
- Ensure that FDA fulfills Generic Drug User Fee Amendments review commitments.
- Conduct and administer research in support of the GDUFA Regulatory Science Plan.
- Interact with external stakeholders such as physicians, pharmacists, patients, and patient advocacy groups to investigate reports of adverse events or therapeutic inequivalence of generic drugs.
- Office of Generic Drugs Immediate Office
- Office of Bioequivalence
- Office of Generic Drug Policy
- Office of Regulatory Operations
- Office of Research and Standards
E-mail: email@example.com | Phone: 240-402-7920 | Fax: 301-595-1147
Office of Generic Drugs, Immediate Office, 10903 New Hampshire Avenue, Silver Spring, MD 20993
- Generic Drugs Program
- First Generic Drug Approvals
- Activities Metrics and Other Reports
- Office of Generic Drugs (OGD) Annual Reports
- 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