- October 27 - 28, 2020
- - ET
- - ET
This conference 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.
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.
- 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
Office of Generic Drugs (OGD) | CDER | FDA
- 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
Recent Orange Book publications include:
- The agency opened a public docket to solicit comments on how stakeholders and the public use the Orange Book and whether and how it can be improved.
- The agency opened a public docket to solicit comments on the listing of patent information in the Orange Book.
- In May 2020, the FDA published a draft guidance for industry, Orange Book Questions and Answers, to assist prospective and current drug product applicants and approved application holders in effectively using the Orange Book, and provide answers to commonly asked questions.
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.
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