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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All written comments should be identified with this document’s docket number: FDA-2024-D-2402.
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Content current as of:
01/06/2025
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