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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

Important Orange Book Facts

Enroll
Step Status
Educational Content ✘
Posttest ✘
Evaluation ✘
Starts On: Wed, 9/18/24: 12:00 AM EDT
Ends On: Fri, 9/17/27: 12:00 AM EDT
Type: Enduring Material
Credits: 1
Description: The purpose of this webinar is to discuss commonly asked questions from the Orange Book Questions and Answers Guidance for Industry. Topics will include Orange Book content and format and how to use the Orange Book to find information on therapeutic equivalence, marketing status, patents and exclusivities.
Objectives:
  • Discuss the inclusion of products in the Orange Book.
  • Utilize the Orange Book to identify therapeutically equivalent products.
  • Recognize the statutory requirements for the movement of drug products between the active and discontinued sections of the Orange Book.
  • Identify the requirements for listing and removing patent information.
  • Distinguish the different types of exclusivities listed in the Orange Book.
Additional Information: Review the Activity Announcement for additional details: Announcement Form