The Food and Drugs Administration’s Office of Generic Drugs (OGD) is a division under the Center for Drug Evaluation in Research (CDER) that focuses on the approval and facilitation of generic drugs. The purpose of the OGD is to ensure that the drug products distributed in the United States (US) are of high quality, and are safe and effective to use. The OGD ensures that the generic drugs distributed in the US have the same active ingredient, strength, dosage form, and route of administration as the brand-name drug.

Responsibilities of the OGD

  • To approve generic drugs by reviewing abbreviated new drug applications (ANDAs)
  • To act as the central point of communication between the FDA and the applicants
  • To guide and oversee the Regulatory scenarios of generic drugs
  • To ensure that the Generic Drug User Fee Amendments commitments are fulfilled
  • To conduct research as per the GDUFA Regulatory Science Plan
  • Investigate adverse event reports or similar reports related to generic drugs by interacting with various healthcare providers

Offices Under the OGD

  1. Office of Generic Drugs Immediate Office
  2. Office of Bioequivalence
  3. Office of Generic Drug Policy
  4. Office of Regulatory Operations
  5. Office of Research and Standards

The review process of the OGD

  • Facilitating approval of drugs by managing the Regulatory process
  • Initiating generic drugs research
  • Gathering and publishing the data & reports on the development & review of generic drugs
  • Providing educational material and related information on generic drugs

The OGD was set up by the FDA to ensure the safety and efficacy of the generic drugs distributed in the US. Are you aligned with the regulations of OGD? Reach out to Freyr for compliance.