Celebrating 40 Years:

An In-Depth Examination of the FDA Orange Book

October 27-28, 2020 | Webcast

This event is FREE.

ABOUT

In the first-ever Orange Book Conference, FDA will showcase the Orange Book and provide a roadmap for the rich information it contains. This conference is a great opportunity for the brand and generic drug industries, and other interested public health stakeholders, to hear from the agency’s Orange Book experts, and provide feedback on its use and functionality.

LEARNING OBJECTIVES

After this conference, participants will be able to…

Identify and use the various types of information in the Orange Book, including therapeutic equivalence ratings, patents, exclusivities, and more.
Describe the origin and history of the Orange Book.
List possible future Orange Book enhancements.

Topics

History of the Orange Book
Orange Book 101
Updates to Orange Book Information
Orange Book Content
Patent Information in the Orange Book
Best Practices for 505(b)(2) and ANDA Applicants
Exclusivity Information in the Orange Book
Therapeutic Equivalence

FDA KEYNOTE SPEAKER ADDRESS

The Future of the Orange Book

Sally Choe, PhD
Director
Office of Generic Drugs (OGD) | CDER | FDA

CONTINUING EDUCATION

Real-time attendance is required for the certificate of attendance. Certificates are only available during the three weeks post-event. This course:

has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
has been pre-approved by SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
has been pre-approved by SQA as eligible for 0.25 non-GCP or non-GLP units for every 1 hour of instructional time towards a participant’s RQAP re-registration.
has been approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.