2009 H1N1 (Swine) flu virus

2009 H1N1 (Swine) Flu Virus
May 12, 2009

Topics on this Page
. Background
. News
. Frequently Asked Questions
. Health Fraud
. Information for Consumers
. Information for Health Care Professionals
. Information for Industry


Background
FDA is working to address human infection with the 2009 H1N1 flu virus as part of a team led by the Department of Health and Human Services.

FDA is responding to this threat by:

working with other government agencies and manufacturers on a series of issues related to antiviral medications
growing the 2009 H1N1 flu virus and preparing to make vaccine seed lots, which may be used eventually to produce a safe and effective vaccine
helping to prepare reagents needed for vaccine production and coordinating closely with other public health agencies for clinical development and testing
accelerating access to new diagnostic tools for this 2009 H1N1 flu virus
To provide the latest information, FDA will update this Web page regularly.

News
Viewpoint: FDA Action and 2009 H1N1 Flu
Testimony of Joshua M. Sharfstein, M.D., Principal Deputy Commissioner and
Acting Commissioner before the Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies (May 7)

FDA Approves New Influenza Vaccine Production Facility (May 6)
Testimony of Joshua M. Sharfstein, M.D., Principal Deputy Commissioner and
Acting Commissioner before the Subcommittee on Health (April 30)
Stockpiled Antivirals at or Nearing Expiration

FDA Authorizes Emergency Use of Influenza Medicines, Diagnostic Test in Response to 2009 H1N1

Flu Virus Outbreak in Humans
All 2009 H1N1 Flu Virus News Releases

Frequently Asked Questions
2009 H1N1 Flu Virus and Antivirals

Personal Protection Equipment for the 2009 H1N1 Flu Virus
2009 H1N1 Flu Virus and Food

Emergency Use Authorization (EUA)
2009 H1N1 Flu Virus and the Food Industry
2009 H1N1 flu virus (PandemicFlu.gov)


Health Fraud
* The U.S. Food and Drug Administration is alerting the public to be wary of Internet sites selling products that claim to prevent, treat or cure 2009 H1N1 flu virus, and is informing offending websites that they must take prompt action to correct and/or remove promotions of these fraudulent products or face immediate enforcement action.

FDA, FTC Warn Public of Fraudulent 2009 H1N1 Influenza Products
. Report Suspected Fraudulent Products or Criminal Activity Associated with H1N1 Flu Virus
. Fraudulent 2009 H1N1 Influenza Products List

Information for Consumers
-- H1N1 Flu: FDA Responds Quickly to Protect the Public's Health New!
-- Frequently Asked Questions: 2009 H1N1 flu virus
-- Questions on 2009 H1N1 Flu Virus and Food
.. FDA and CDC Information on Potential “Spot Shortages” of Supplies for Treating and Preventing Novel Influenza A (H1N1)

Frequently Asked Questions: Personal Protection Equipment for the 2009 H1N1 Flu Virus
FDA Regulated Products

Drug Treatments for Flu
**** Tamiflu and Relenza are the two FDA-approved influenza antiviral drugs that are recommended by CDC for use against the 2009 H1N1 influenza virus. EUAs have been issued for specific uses of these two drugs in the current 2009 H1N1 setting.

Personal Protective Equipment (PPE)
ºººº Information about masks, gloves, and gowns used to prevent the spread of germs from one person to another

Test Kits
⌂⌂⌂ Information about potential risks and benefits of the H1N1 Flu Test Kit

Biologics: Vaccines and Blood Safety
... 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.

Information for Health Care Professionals
*** Frequently Asked Questions: 2009 H1N1 flu virus
**** Dear Health Care Professionals letter
***** FDA Regulated Products

Drug Treatments for Flu
** Tamiflu and Relenza are the two FDA-approved influenza antiviral drugs that are recommended by CDC for use against the 2009 H1N1 influenza virus. EUAs have been issued for specific uses of these two drugs in the current 2009 H1N1 setting.

Personal Protective Equipment (PPE)---- Information about masks, gloves, and gowns used to prevent the spread of germs from one person to another.

Medical Devices for Flu Diagnosis and Protection
--- Information about H1N1 influenza test kits and N95 respirators. FDA issued emergency use authorizations for some of these products in late April and early May.

Biologics: Vaccines and Blood Safety
-- 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.

More Information
- FDA Authorizes Emergency Use of Influenza Medicines, Diagnostic Test in Response to 2009 H1N1 Flu Virus Outbreak in Humans
- Frequently Asked Questions about Emergency Use Authorization (EUA)


Information for Industry
* Questions and Answers on the 2009 H1N1 Flu Virus and the Food Industry

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2009 H1N1 (Swine) flu virus



http://www.fda.gov/h1n1flu/default.htm