The Oncology Center of Excellence (OCE) Project Point/Counterpoint provides a new version of the Oncologic Drugs Advisory Committee (ODAC) briefing document that combines the company’s and the FDA’s positions in one document, similar to the OCE Assessment Aid. The new briefing document increases the transparency of differences in viewpoints and is more concise to focus on salient data and facilitate the committee’s understanding of the critical issues for discussion.
The new briefing document was first piloted for the December 17, 2019, ODAC meeting. An updated template was subsequently used to create the briefing documents for the ODAC meetings convened on July 14, 2020, and February 9, 2021; and for the six products discussed over the three-day meeting held on April 27-29, 2021.
The Combined FDA and Applicant ODAC Briefing Document serves as a stand-alone document (i.e., the information and supportive evidence provided should be self-sufficient) containing the background information and an objective description of the data for the clinical trial or subject under discussion at ODAC followed by the positions of both the applicant and the FDA. The document, including tables and figures, should not exceed 35 pages.
The briefing document is submitted to the Office of Oncologic Diseases review Division three to five weeks prior to the traditional FDA advisory committee briefing document due date. All other advisory committee timelines (e.g., sharing with the applicant and public posting) for the combined briefing document remain the same as the timelines for the traditional briefing document process.
Applicants are offered the opportunity to use the combined briefing document in lieu of a traditional briefing document. Applicants do not edit the FDA portion, nor can they edit their portion after submitting the combined briefing document. However, updates and corrections to the combined briefing document can be made via an addendum or errata, respectively.
For Further Information
- Oncology Regulatory Affairs
- Assessment Aid
- Office of Oncologic Diseases (OOD)
- OOD Divisions and Contact Information
- Information for Sponsors: Submissions to the Office of Oncologic Diseases (OOD)