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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines, Blood & Biologics Topics


Allergen Patch Tests, Allergenic Extracts

Blood & Blood Products

Blood, Blood Components, Blood Bank Devices, Blood Donor Screening Tests

Cellular & Gene Therapy Products

Gene-based Treatments, Cell-based Treatments, Cloning

Tissue & Tissue Products

Bone, Skin, Corneas, Ligaments, Tendons, Stem Cells, Sperm, Heart Valves


Vaccines for Use in Children and Adults, Tuberculin Testing


Transplantation of Non-Human Cells, Tissues or Organs Into a Human

International Activities

PAHO/WHO Activities, Building Regulatory Capacity

Development & Approval Process (Biologics)

Labeling, Advertising, IND, PMA, BLA, NDA, 510(k)

Guidance, Compliance & Regulatory Information (Biologics)

Guidance, Rules, SOPPS, Establishment Registration, Enforcement, Compliance

Safety & Availability (Biologics)

Recalls, Shortages, Biological Product Deviation Reporting, Adverse Event Reporting, HIV Home Test Kits

Science & Research (Biologics)

Research by FDA Staff to Evaluate and Enhance the Safety of Biologic Products

News & Events (Biologics)

What's New, Meetings & Workshops

Resources for You (Biologics)

For Consumers, Health Professionals, Industry


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