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Vaccines, Blood & Biologics
Guidance, Compliance & Regulatory Information (Biologics)

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Healthcare Providers (Biologics)
Industry (Biologics)
About the Center for Biologics Evaluation and Research

Guidance, Compliance & Regulatory Information (Biologics)

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Rules & Guidances

Biologics Rules
General Biologics Guidances
Allergenics Guidances
Blood Guidances
Cellular & Gene Therapy Guidances
Tissue Guidances
Xenotransplantation Guidances
Other Recommendations for Biologics Manufacturers
Advisory Committee Guidance Documents

Compliance & Enforcement

Compliance Actions (Biologics)
Enforcement Actions (CBER)
Importing & Exporting (Biologics)
Product Surveillance (CBER)
Letters to Industry / Healthcare Providers / Clinical Investigators

Regulatory Information

Blood Establishment Registration and Product Listing
Tissue Establishment Registration
Regulatory Actions Issued by CBER
Regulation of the Blood Supply
Regulation of Tissues

Post-Market Activities

Lot Distribution Data (LDD) Electronic Submission
Influenza Virus Vaccine Lot Release
Postmarketing Clinical Trials
Postmarketing Reports

Forms

Biologic Forms

Recalls & Alerts

Biologic Product Shortages

Approvals & Clearances

Biologics Products & Establishments

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