Combined FDA and sponsor oncologic drugs advisory committee briefing document
The FDA has announced the availability of a draft guidance for industry entitled “Combined FDA and Sponsor Oncologic Drugs Advisory Committee (ODAC) Briefing Document.” It provides recommendations to sponsors regarding 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. This document includes information that customarily would be contained in separate briefing documents prepared individually by the Sponsor and FDA. Comments can be submitted until 28th February 2025.
News reported on the 31st of January 2025 in Catapult’s regulatory round-up, read the entire report here.
OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (20 mai 2025). Combined FDA and sponsor oncologic drugs advisory committee briefing document. ELSIBI. Consulté le 19 février 2026 à l’adresse https://doi.org/10.58079/13yf2





