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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

Orange Book: Frequently Asked Questions and Answers

Step Status
Educational Content
Starts On: Fri, 3/11/22: 12:00 AM EST
Ends On: Sun, 12/31/23: 11:45 PM EST
Type: Enduring Material
Credits: 1
Description: This webinar was intended to assist stakeholders in utilizing the Orange Book. It addressed some of the most frequently asked questions that the FDA has received from interested parties regarding the Orange Book.
  • Utilize the Orange Book to identify therapeutically equivalent products
  • Identify the regulatory requirements for submission of patent information to the FDA
  • Recognize the statutory requirements for the movement of drug products between the active and discontinued sections of the Orange Book and the Orange Book timing for publication
  • Employ the Orange Book website to locate relevant regulatory information
Additional Information: Review the Activity Announcement for additional details: Announcement Form

Additional Resources: SLIDES