Considerations for Including Tissue Biopsies in Clinical Trials
Guidance for Industry, Investigators, Institutions, and Institutional Review Boards
DRAFT GUIDANCE
This guidance document is being distributed for comment purposes only.
Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Comments also may be submitted to the Office for Human Research Protections, Division of Policy and Assurances, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.
For questions regarding this draft document, contact (OCE/CDER) Jennifer Gao at [email protected], (OCLiP) Jose Pablo Morales at [email protected], or the Office for Human Research Protections, Division of Policy and Assurances at [email protected], 240-453-6900 or 866-447-4777.
Read more: Considerations for Including Tissue Biopsies in Clinical TrialsU.S. Department of Health and Human Services
Food and Drug Administration
Oncology Center of Excellence (OCE)
Office of Clinical Policy (OCLiP)
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
Center for Devices and Radiological Health (CDRH)
U.S. Department of Health and Human Services
Office for Human Research Protections (OHRP)
Date
Clinical/Medical
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Office of Policy
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave., Bldg. 66, Rm. 5431
Silver Spring, MD 20993-0002
Email: [email protected]
https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products
Division of Policy and Assurances
Office for Human Research Protections
1101 Wootton Parkway, Suite 200
Rockville, MD 20852
Phone: 240-453-6900 or 866-447-4777
https://www.hhs.gov/ohrp/regulations-and-policy/index.html
U.S. Department of Health and Human Services
Food and Drug Administration
Oncology Center of Excellence (OCE)
Office of Clinical Policy (OCLiP)
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
Center for Devices and Radiological Health (CDRH)
U.S. Department of Health and Human Services
Office for Human Research Protections (OHRP)