The US FDA Generic Drug Program – The Framework to "Sameness"

On-Demand Webinar Recording

In this webinar...

Understanding what drugs are substitutable for the reference listed drugs requires an understanding of the legal, regulatory, and scientific framework and challenges for demonstrating the “sameness” of a proposed generic drug product compared to an innovator drug. This webinar will provide an overview of the legal framework for how generic drugs can be developed for approval in the United States. Additionally, speakers will discuss the regulatory and scientific framework for determining therapeutic equivalence and challenges that arise with the review and approval of abbreviated new drug applications (ANDAs) for generic drugs.

Learning Objectives

  • Recognize the unique legislative framework regulating generic drugs in the United States
  • Describe different approaches to “equivalence” in drug attributes and the relevance to clinical use
  • Identify specific challenges for demonstrating therapeutic equivalence for different generic drug products

Presenter

  • Sarah Yim, MD, Director, Division of Clinical Review, Office of Generic Drugs, FDA
  • Raquel Tapia, MD, Medical Officer/Reviewer, Division of Clinical Review, Office of Generic Drugs, FDA