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Vaccines, Blood & Biologics
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Resources for You
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Clinical Investigator Information
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Conducting a Clinical Investigation
- Running Clinical Trials
FDA's Office of Science & Research - Investigational New Drug (IND) Guidances
- Clinical 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 Health - Clinical 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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Rules
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Related Links
- Introduction to the Regulatory Process for Clinical Investigators (National Institutes of Health)
A training course for employees of the Department of Health and Human Services. - ClinicalTrials.gov
A registry of federally and privately supported clinical trials conducted in the United States and around the world; a service of the U.S. National Institutes of Health.
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Contact Us
Manufacturers Assistance and Technical Training Branch (CBER)
- (800) 835-4709
- (301) 827-1800
- matt@fda.hhs.gov
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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