Vaccines, Blood & Biologics

Allergenics

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

Guidance, Compliance & Regulatory Information (Biologics)

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

Tissue & Tissue Products

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

Vaccines

Vaccines for Use in Children and Adults, Tuberculin Testing

Xenotransplantation

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

Development & Approval Process (CBER)

Advertising & Labeling, IND, Expanded Access, PMA, BLA, NDA, 510(k)

Safety & Availability (Biologics)

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

International Activities

Regulatory Harmonization/ Convergence, WHO Engagements, Resources for Foreign Regulators

Science & Research (Biologics)

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

Resources for You (Biologics)

Information for Consumers, Health Professionals, Industry

News & Events (Biologics)

Latest news and event information from the Center for Biologics Evaluation and Research at FDA

Fecal Microbiota Products

Information about Fecal Microbiota Products

Center for Biologics Evaluation and Research (CBER)

Information About CBER