🧬FDA Guidance on Tissue Biopsies in Clinical Trials for Businesses
Considerations for Including Tissue Biopsies in Clinical Trials; Draft Guidance for Industry, Investigators, Institutions, and Institutional Review Boards; Availability
Summary
The Food and Drug Administration (FDA or Agency) and the Office for Human Research Protections (OHRP) are announcing the availability of a draft guidance for industry, clinical investigators, institutions, and institutional review boards (IRBs) entitled "Considerations for Including Tissue Biopsies in Clinical Trials." This guidance provides recommendations regarding considerations for tissue biopsies that may be conducted in adults and in children as part of clinical trials evaluating investigational medical products and/or that are conducted or supported by the Department of Health and Human Services (HHS).
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The FDA's draft guidance on including tissue biopsies in clinical trials impacts compliance and regulatory requirements for businesses involved in clinical research. Companies must consider the recommendations when designing trials, ensuring they adhere to FDA guidelines and are prepared to address any associated risks.