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GUIDANCE DOCUMENT

Considerations for Including Tissue Biopsies in Clinical Trials January 2025

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2024-D-2402
Issued by:
Guidance Issuing Office
Oncology Center of Excellence

This guidance provides recommendations to industry, investigators, institutions, and institutional review boards (IRBs) regarding considerations for tissue biopsies that may be conducted in adults and in children as part of clinical trials that evaluate investigational medical products and/or that are conducted or supported by the Department of Health and Human Services (HHS). For the purposes of this guidance, a biopsy is a procedure that involves acquisition of tissue from a trial participant as part of a clinical trial protocol. Biopsies needed to inform routine clinical care are not included in this guidance.

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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-2402.

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