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# FDA Seeks Comments on ODAC Briefing Guidance
- URL: https://www.fdaweb.com/fda-seeks-comments-on-odac-briefing-guidance/
- Published: 2025-01-02T12:00:00.000Z
- Updated: 2026-09-14T14:49:26.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158384

FDA says it will accept until 2/28 comments on a draft guidance entitled *Combined FDA and Sponsor Oncologic Drugs Advisory Committee (ODAC) Briefing Document*. A *Federal Register* [announcement](defining,%20identifying,%20and%20reporting%20protocol%20deviations%20in%20clinical%20investigations.) says the draft guidance contains recommendations for sponsors on the use and development of a combined version of the ODAC briefing document, as part of the Oncology Center of Excellence’s Project Point/Counterpoint Initiative.

Project Point/Counterpoint, the announcement says, is an option for advisory committee meetings for oncology products. It says the 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.