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Vaccines, Blood & Biologics

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Gardasil is approved for females 9 to 26 years old.

Gardasil Vaccine Safety

FDA and CDC have been closely monitoring the safety of Gardasil.

Sick child is a reminder to get a flu vaccination this year

Influenza Virus Vaccine for the 2009-2010 Season

Flu vaccine availability and formulation

Cellular therapies and gene therapies have the potential to treat chronic diseases such as diabetes.

Cellular & Gene Therapy Products

Gene-based Treatments, Cell-based Treatments, Cloning

 
 
Allergenics

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

Vaccines for Use in Children and Adults, Tuberculin Testing

Xenotransplantation

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

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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Approvals & Clearances

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Contact Us

  • (800) 835-4709
  • (301) 827-1800
  • Consumer Affairs Branch (CBER)

    Division of Communication and Consumer Affairs

    Office of Communication, Outreach and Development

    Food and Drug Administration

    1401 Rockville Pike

    Suite 200N/HFM-47

    Rockville, MD 20852-1448

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