Vaccines, Blood & Biologics
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Guidance, Compliance & Regulatory Information (Biologics)
Should you find a link that does not work that's embedded within Guidance documents, Rules, and other documents posted on the FDA Web site, 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 Vaccine and Related Biological Product 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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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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