Celebrating 40 Years:
An In-Depth Examination of the FDA Orange Book
October 27 & 28, 2020
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 2, updated on September 21, 2020.
The speaker biographies document is under development and will be posted here when it is completed.
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 on the Past Events page 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 links will become active the day of the event.
The above rooms will open ~15 minutes before each day begins.
If you encounter any technical issues, visit the Technical Issues Support Page
The ZIP files above will be available for download 24 hours before the event.
The above link will become active at the conclusion of the event.
If you have questions regarding the content of the event or other CDER-specific information, please: