Vaccines, Blood & Biologics

Navigate the Vaccines, Blood & Biologics Section


Allergen Extracts, Allergen Patch Tests, Antigen Skin Test

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)

Advertising & Labeling, IND, Expanded Access, 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

Subscribe to Biologics Updates

Page Last Updated: 04/12/2019
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