Top
US_Flag An official website of the United States government Here's how you know
GOV

The .gov means it's official.

Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

LOCK

The site is secure.

The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

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

Q&A with FDA Podcast: Generics-at-a-Glance with Dr. Sarah Ibrahim

Enroll
Step Status
Educational Content ✘
Posttest ✘
Evaluation ✘
Starts On: Tue, 2/20/24: 12:00 AM EST
Ends On: Sun, 1/17/27: 12:00 AM EST
Type: Enduring Material
Credits: 0.5
Description: This enduring material provides an overview of generic drug regulation and how the FDA ensures generic drugs are safe, effective and of high-quality for the American public. It highlights the rigorous scientific and regulatory review process as well as the post-marketing activities.
Objectives:
  • Describe the regulatory framework for generic drug approval in the United States.
  • Identify what information a company must submit as part of an Abbreviated New Drug Application (ANDA) including how firms must establish pharmaceutical equivalence, demonstrate bioequivalence, and the how they intend to manufacture the product to meet quality standards.
  • Explain how the FDA monitors generic drugs post-approval.
Additional Information: Review the Activity Announcement for additional details: Announcement Form