Vaccines, Blood & Biologics
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2009 H1N1 (Swine) Flu Virus (Biologics)
CBER's Vaccine and Blood Teams are working to facilitate the availability of safe and effective vaccines and ensuring that the blood supply is not affected by the H1N1 Flu Virus.
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Influenza A (H1N1) Monovalent Vaccine
Influenza A (H1N1) 2009 Monovalent Influenza A (H1N1) 2009 Monovalent Vaccines Questions and Answers Monovalent Influenza Vaccine Dosage, Administration, and Storage (CDC) Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release Influenza A (H1N1) 2009 Monovalent Vaccine Safety Monitoring Vaccine Information Statement (VIS) for Inactivated 2009 H1N1 Influenza Vaccine Vaccine Information Statement (VIS) for Live, Intranasal 2009 H1N1 Influenza Vaccine Influenza A (H1N1) 2009 Monovalent Vaccine (CSL Limited) Influenza A (H1N1) 2009 Monovalent Vaccine (ID Biomedical Corporation of Quebec) Influenza A (H1N1) 2009 Monovalent Vaccine (MedImmune LLC) Influenza A (H1N1) 2009 Monovalent Vaccine (Novartis Vaccines and Diagnostics Limited) Influenza A (H1N1) 2009 Monovalent Vaccine (Sanofi Pasteur, Inc.) Influenza Virus Vaccine Actions FDA Approves Vaccines for 2009 H1N1 Influenza Virus
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General
Novel H1N1 Vaccination Recommendations FDA 2009 H1N1 (Swine) Flu Page H1N1 Flu: FDA Responds Quickly to Protect the Public's Health Updated Questions and Answers: 2009 H1N1 Flu Virus and Emergency Use Authorization of Tamiflu and Relenza Use of Influenza A (H1N1) 2009 Monovalent Influenza Vaccine in Pregnant Women FDA Approves New Influenza Vaccine Production Facility Information about Newly Emerging 2009 H1N1 Influenza Virus and Blood Safety Guidance for Industry: Recommendations for Blood Establishments: Training of Back-Up Personnel, Assessment of Blood Donor Suitability and Reporting Certain Changes to an Approved Application (PDF - 49KB)
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Press Releases
FDA Clears First 2009 H1N1 Influenza Virus Test Previously Approved for Emergency-Use Only
Press Release: May 24, 2010FDA Commissioner Addresses Nation's Health Care Professionals on H1N1 Vaccine Safety
Press Release: January 14, 2010FDA Approves Vaccines for 2009 H1N1 Influenza Virus
Press Release: September 15, 2009Updated Federal Guidelines for 2009 H1N1 Influenza in Schools Offer Many Options
Press Release: August 7, 2009FDA Authorizes Emergency Use of Another Test for 2009 H1N1 Influenza Virus
Press Release: July 24, 2009FDA Warns Web Sites against Marketing Fraudulent H1N1 Flu Virus Claims
Press Release: June 15, 2009Statements by HHS Secretary Kathleen Sebelius and DHS Secretary Janet Napolitano on WHO Decision to Declare Novel H1N1 Virus Outbreak a Pandemic
Press Release: June 11, 2009Stockpiled Antivirals at or Nearing Expiration FDA Authorizes Emergency Use of Influenza Medicines, Diagnostic Test in Response to Swine Flu Outbreak in Humans
Press Release: April 27, 2009
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Related Information
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Contact FDA
(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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