Vaccines, Blood & Biologics
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Clinical Investigator Information
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Conducting a Clinical Investigation
Clinical Trials
FDA's Office of Science & ResearchClinical Trials Guidance Documents Clinical Trials Guidance Documents Section 8200: Investigational New Drugs (INDs)
Standard Operating Policies & Procedures (CBER)Participation of Females in Clinical Trials and Gender Analysis of Data in Biologic Product Applications
A research study funded by the FDA Office of Women's HealthClinical Hold / Refusal to File Meetings FDA 101: Clinical Trials and Institutional Review Boards
For Consumers
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Compliance, Enforcement, Investigations
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Contact FDA
(800) 835-4709
(301) 827-1800
Manufacturers Assistance and Technical Training Branch (CBER)
Division of Manufacturers Assistance and Training
Office of Communication, Outreach and Development
Food and Drug Administration
1401 Rockville Pike
Suite 200N/HFM-41
Rockville, MD 20852-1448
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