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U.S. Food & Drug Administration
Continuing Education and Accreditation
Division of Learning and Organizational Development
Center for Drug Evaluation and Research

The Safety Evaluation and Surveillance of Generic Drugs

Enroll
Step Status
Educational Content ✘
Posttest ✘
Evaluation ✘
Starts On: Fri, 2/3/23: 12:00 AM EST
Ends On: Wed, 12/31/25: 12:00 AM EST
Type: Enduring Material
Credits: 1.5
Description: In the United States, 9 out of 10 prescriptions filled are for generic drugs. The Office of Generic Drugs (OGD) within the Center for Drug Evaluation and Research (CDER) follows a rigorous review process to ensure drug products that are approved in Abbreviated New Drug Applications (ANDAs) are of high quality, safe and considered by FDA to be therapeutically equivalent to their Reference Listed Drug (RLD).

This webinar provides health care professionals with information on the evaluations performed, methods, and tools used by OGD's Office of Safety and Clinical Evaluation (OSCE) to assess the safety and effectiveness of generic drugs throughout the life-cycle of the product (e.g., pre-market and post-market setting).
Objectives:
  • Review the methods used by FDA to monitor the safety and effectiveness of generic drugs in the pre-market and post-market setting
  • Identify scenarios and approaches when OGD Pharmacology/Toxicology assesses the safety of excipients in generic drug products
  • Describe the sources of drug impurities and how OGD Pharmacology/Toxicology assesses their safety in generic drug products and drug master files
  • Recognize how comparative clinical studies and other assessments are used to evaluate the bioequivalence and comparative safety of new potential generic drug products
Additional Information: Review the Activity Announcement for additional details: Announcement Form

Additional Resources: Slides