New York/New Jersey Chapter Webcast: After 40 Years, is FDA’s Orange Book in Store for a Facelift?

RAC Credits
Friday, 14 August 2020 (12:00 PM) - Friday, 14 August 2020 (1:00 PM) Eastern Time (US & Canada)

Member: FREE
Nonmember: $20

Your participation in the regulatory community is vital. Currently, RAPS Chapter in-person events are converted to webcasts so that regulatory professionals have online access to valuable knowledge necessary to understand the daily impact on our industry. RAPS is offering this webcast for free to members and $20 for non-members.


FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the “Orange Book,” is a tome of indispensable drug product information, and is perhaps the most widely used and referenced publication. It lists patent exclusivity and therapeutic equivalence information for approved drugs, as part of its effort to increase drug competition. The Orange Book has undergone various changes throughout the four decades it has been around. Now, FDA is seeking comments on what could result in a more substantial transformation of the publication. 

This presentation will review the publication’s current status and discuss the possible modifications and enhancements we might see. There will be a Q&A session at the end. 

This event is brought to you by the RAPS New York/New Jersey Chapter to encourage knowledge sharing and community development. RAC holders may claim 1.0 RAC recertification credits.

Learning Level: Intermediate

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.

This webcast is available to RAPS members for free. RAPS membership provides vital information for regulatory professionals, as well as a place for networking and invaluable connections. Now is a great time to explore the many benefits to RAPS membership, including the Member Knowledge Center and our award-winning, private online community, Regulatory Exchange. 

Find out more about RAPS membership today.

How Do Webcasts Work?

For the best webcast experience, please use the Google Chrome browser. RAPS webcasts are also mobile- and tablet-accessible for your convenience. Registrants will receive instructions on how to log in 24 hours before the start of the webcast. A live Q&A portion with the speaker will follow the presentation. 

Featured Speaker:
Kurt R. Karst, director, attorney, Hyman, Phelps & McNamara, P.C.