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2025
- doi: 10.58079/13yf2
info:eu-repo/semantics/openAccess
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adelage, « Combined FDA and sponsor oncologic drugs advisory committee briefing document », ELSIBI, ID : 10.58079/13yf2
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The FDA has announced the availability of a draft guidance for industry entitled “Combined FDA and Sponsor Oncologic Drugs Advisory Committee (ODAC) Briefing Document.”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...
