Combined Food and Drug Administration and Sponsor Oncologic Drugs Advisory Committee Briefing Document; Draft Guidance for Industry; Availability

概要

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Combined FDA and Sponsor Oncologic Drugs Advisory Committee (ODAC) Briefing Document." This draft guidance provides recommendations to sponsors regarding use and development of a combined version of the ODAC briefing document, as part of the Oncology Center of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. Sponsors in non-oncology therapeutic areas who want to discuss whether a combined advisory committee briefing document may be appropriate for their applications should contact the relevant review division. This briefing document format may provide efficiencies by allowing Sponsors and FDA to choose to use a single document that provides the views of the Sponsor and FDA on key issues.