Combined Food and Drug Administration and Sponsor Oncologic Drugs Advisory Committee Briefing Document

Issue Date: December 27, 2024
Issued by: Oncology Center of Excellence
Topic(s): Prescription Drugs, Oncology
Status: Draft

Combined Food and Drug Administration and Sponsor Oncologic Drugs Advisory Committee Briefing Document

The FDA is announcing the availability of a draft guidance for industry entitled “Combined FDA and Sponsor Oncologic Drugs Advisory Committee (ODAC) Briefing Document.” This draft guidance provides recommendations to sponsors regarding use and development of a combined version of the ODAC briefing document, as part of the Oncology Center of Excellence’s (OCE) Project Point/Counterpoint initiative. This single document includes information that customarily would be contained in separate briefing documents prepared individually by the Sponsor and FDA. Project Point/Counterpoint is an option for advisory committee meetings for oncology products.

Download the Guidance Document