Celebrating 40 Years:
An In-Depth Examination of the FDA Orange Book
October 27 & 28, 2020
Updated Start Time: 9:15 AM (Eastern)
This event is FREE
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.
Sally Choe, PhD
- 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
Who Should Attend?
- Representatives of companies working on, and/or who hold approved ANDAs, and/or NDAs
- Consultants serving above companies
- Healthcare professionals and pharmacists who work with patients to select and identify therapeutic equivalents
Continuing Education Credit
- 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.
- Continuing education certificates are available only for those who attend real-time. There is a three week deadline to obtain the certificate of attendance and complete the event survey.
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.
The virtual conference will be hosted via Adobe Connect and is limited to 2,000 simultaneous attendees (1,000 each in Room One and Room Two). If a room is full when you attempt to enter, please try the other room. The recordings of each of the sessions will be posted below within 24 hours.
The links below to the Adobe Connect room for each track will be activated shortly before the event begins.
Please select the correct room based on the first letter of your LAST NAME.
The above rooms will open ~15 minutes before each day begins.
If you encounter any technical issues, visit the Technical Issues Support Page
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 (recording link coming soon)
- 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 (recording link coming soon)
- 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: