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Zdrowie i gospodarka · 07/01/2025

Considerations for Including Tissue Biopsies in Clinical Trials; Draft Guidance for Industry, Investigators, Institutions, and Institutional Review Boards; Availability

The FDA and OHRP have released a draft guidance on including tissue biopsies in clinical trials, providing recommendations for industry, investigators, institutions, and IRBs. The guidance addresses tissue biopsies in adults and children as part of clinical trials evaluating investigational medical products.

Source: Federal Register — Food and Drug AdministrationOpen original release →