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1、 35086309fnl04-07-23.docx A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers Guidance for Industry U.S.Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research(CDER)Center for Biologics Evaluation and Research(CBER

2、)Center for Devices and Radiological Health(CDRH)Office of Clinical Policy(OCLiP)Office of Regulatory Affairs(ORA)April 2023 Procedural A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers Guidance for Industry Additional copies are available from:Office of Communicat

3、ions,Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 10001 New Hampshire Ave.,Hillandale Bldg.,4th Floor Silver Spring,MD 20993-0002 Phone:855-543-3784 or 301-796-3400;Fax:301-431-6353 Email:druginfofda.hhs.gov https:/www.fda.gov/Drugs/GuidanceCompli

4、anceRegulatoryInformation/Guidances/default.htm and/or Office of Communication,Outreach and Development Center for Biologics Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave.,Bldg.71,Room 3128 Silver Spring,MD 20993-0002 Phone:800-835-4709 or 240-402-8010 Email:ocodfda.hh

5、s.gov https:/www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances and/or Office of Policy Center for Devices and Radiological Health Food and Drug Administration 10903 New Hampshire Ave.,Bldg.66,Room 5431 Silver Spring,MD 20993-0002 Email:CDRH

6、-Guidancefda.hhs.gov https:/www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products U.S.Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research(CDER)Center fo