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FREE 1.5 hrs CE “live” virtual webinar on FDA Drug Topics: The Safety Evaluation and Surveillance of Generic Drugs
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).