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GUIDANCE DOCUMENT

Combined Food and Drug Administration and Sponsor Oncologic Drugs Advisory Committee Briefing Document December 2024

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2024-D-4490
Issued by:
Guidance Issuing Office
Oncology Center of Excellence

The FDA is announcing the availability of a draft guidance for industry entitled “Combined FDA and Sponsor Oncologic Drugs Advisory Committee (ODAC) Briefing Document.”  This draft guidance provides recommendations to sponsors regarding use and development of a combined version of the ODAC briefing document, as part of the Oncology Center of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

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Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2024-D-4490.

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