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The FDA is announcing the availability of a draft guidance for industry entitled “Combined FDA and Sponsor Oncologic Drugs Advisory Committee (ODAC) Briefing Document.”  This draft guidance provides recommendations to sponsors regarding use and development of a combined version of the ODAC briefing document, as part of the Oncology Center of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.