Celebrating 40 Years:
An In-Depth Examination of the FDA Orange Book
October 27 & 28, 2020
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.
The agenda may be updated over time. The current version is Version 5, updated on October 22, 2020.
The speaker biographies document provides detailed information on the Conference speakers.
Links to recordings will be added as they become available.
- Opening Remarks (Sally Choe) and FDA’s Orange Book: A Historical Review of 40 Years (Kendra Stewart)
- Orange Book 101: An Overview of FDA’s Orange Book – Camille Smith
- How to Update Orange Book Information and Related Considerations – Kendra Stewart, Kun Shen, and Eunice Chung-Davies
- Q&A Panel – Speakers from above and Elizabeth Friedman
- An Overview of FDA’s Patent Listing Process – Kun Shen
- Changes to Orange Book Patent Information – Alicia Chen
- Q&A Panel – Speakers from above and Janice Weiner
- The Patent Information Dispute Process – Alicia Chen
- Best Practices for 505(b)(2) and ANDA Applicants – Andrew Coogan and Mary Ann Holovac
- Q&A Panel – Speakers from above and Jennifer Gerton
- Orange Book Exclusivity: An Introduction and Overview – Truong Quach
- Orange Book Exclusivity: Part I – NCE and 3-Year – Nisha Shah
- Q&A Panel – Speakers from above and Alicia Chen and Christopher Pruitt
- Orange Book Exclusivity: Part II – Pediatric, Orphan, and GAIN – Kristiana Brugger, Aaron Friedman, and Katherine Schumann
- Orange Book Exclusivity: Part III – 180-Day and Competitive Generic Therapy Exclusivities – Jonathan Hughes and Mindy Ehrenfried
- Q&A Panel – Speakers from above
- Orange Book: An Overview of Therapeutic Equivalence (includes Q&A Panel) – Elizabeth Friedman (joining Q&A: Kendra Stewart and James Myers)
- Referencing Approved Drug Products in ANDA Submissions (includes Q&A Panel) – James Hanratty and Timothy Kim (joining Q&A: Kendra Stewart and Susan Levine)
- Orange Book: Looking Towards the Future – Kendra Stewart
- Closing Remarks – Maryll Toufanian
If you have questions regarding the content of the event or other CDER-specific information, please: