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                Center for Drug Evaluation and Research | CDER

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          Center for Drug Evaluation and Research | CDER
          Office of Generic DrugsCenter for Drug Evaluation and Research | CDER Office of Generic Drugs

    
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The Office of Generic Drugs (OGD) ensures high-quality, affordable generic drugs are available to the American public. 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 five subordinate offices, totaling more than 600 employees.

What We Do:

Review applications for the approval of generic drugs (known as abbreviated new drug applications or ANDAs).
	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 Organization:

Office of Generic Drugs Immediate Office
	Office of Bioequivalence
	Office of Generic Drug Policy
	Office of Regulatory Operations
	Office of Research and Standards
	Office of Safety and Clinical EvaluationContact Us:

E-mail: genericdrugs@fda.hhs.gov | Phone: 240-402-7920 | Fax: 301-595-1147
	Office of Generic Drugs, Immediate Office, 10903 New Hampshire Avenue, Silver Spring, MD 20993
	OGD Division of Project Management Contact ListAdditional Resources

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

                                                                                  Content current as of:
      08/05/2022Center for Drug Evaluation and Research | CDER
            
          
                        CDER Offices and Divisions
          Meeting Presentations | Drugs
          CDER Exclusivity Board


                        Accelerating Rare disease Cures (ARC) Program
          CDER Contact Information
          CDER Manual of Policies & Procedures | MAPP
          Frequently Asked Questions about CDER
          Reports & Budgets | CDER
 
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