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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 As a result, some Web links (URLs) embedded within Guidance documents, Rules, and other documents are no longer valid.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
- Biologics Rules
- General Biologics Guidances
- Allergenics Guidances
- Blood Guidances
- Cellular & Gene Therapy Guidances
- Tissue Guidances
- Vaccines Guidances
- Xenotransplantation Guidances
- Other Recommendations for Biologics Manufacturers
- Advisory Committee Guidance Documents
- Clinical Trials Guidance Documents
- Combination Products Guidance Documents
- Import and Export Guidance Documents
- International Conference on Harmonization (ICH) Guidance Documents
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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
- (800) 835-4709
- (301) 827-1800
- matt@fda.hhs.gov
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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