FDA Surveillance and H1N1 Preparedness

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The page below is a sample from the LabCE course The Influenza A Virus: 2009 H1N1 Subtype. Access the complete course and earn ASCLS P.A.C.E.-approved continuing education credits by subscribing online.

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FDA Surveillance and H1N1 Preparedness

The US Food and Drug Administration's (FDA) worked with the CDC and other health agencies, both in the United States and globally, to protect public health during the H1N1 virus outbreak.

The FDA ensures the safety, effectiveness, and supply of antiviral medications and the H1N1 vaccine that is produced and/or distributed in the United States; it has the responsibility of approving medical devices for the serologic testing of the 2009 H1N1 virus. The FDA also performs other roles such as ensuring the production of an adequate supply of respiratory protection and other personal protective equipment. The FDA also monitors the safety of the blood supply, and, although no cases of transmission of H1N1 virus through blood have been reported, the guidelines for donor deferral that have been established by the FDA further ensure that this would not occur.