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Vaccines, Blood & Biologics
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Resources for You
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Guidance, Compliance & Regulatory Information (Biologics)
We have recently redesigned the FDA Web site. As a result, some Web links (URLs) embedded within Guidance documents, Rules, and other documents are no longer valid. If you find a link that does not work, please try searching for the document using the document title. For more assistance, go to Contact FDA.
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Rules, Guidances & Recommendations
Biologics Rules Other Recommendations for Biologics Manufacturers General Biologics Guidances Allergenics Guidances Blood Guidances Cellular & Gene Therapy Guidances Tissue Guidances Vaccines Guidances Xenotransplantation Guidances Advisory Committee Guidance Documents Clinical Trials Guidance Documents Combination Products Guidance Documents Guidances (Drugs) Import and Export Guidance Documents International Conference on Harmonisation - Efficacy International Conference on Harmonisation - Joint Safety/Efficacy (Multidisciplinary) International Conference on Harmonisation - Quality International Conference on Harmonisation - Safety
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Compliance & Enforcement
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Regulatory Information
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Post-Market Activities
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Recalls & Alerts
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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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