FDA - Flu Meds and Swine Flu Tests »
Posted By austinl7 8 months, 1 week ago in Health & FitnessThe U.S. Food and Drug Administration (FDA), in response to requests from the U.S. Centers for Disease Control (CDC) and Prevention, has issued Emergency Use Authorizations (EUAs) to make available to public health and medical personnel important diagnostic and therapeutic tools to identify and respond to the swine flu virus under certain circumstances. The agency issued these EUAs for the use of certain Relenza and Tamiflu antiviral products, and for the rRT-PCR Swine Flu Panel diagnostic test, reports this FDA news release, "FDA Authorizes Emergency Use of Influenza Medicines, Diagnostic Test in Response to Swine Flu Outbreak in Humans."
In essence, this authorizes the use of unapproved or uncleared medical products or unapproved or uncleared uses of approved or cleared medical products, made possible by this determination and declaration of emergency, provided certain criteria are met. The authorization ends when the declaration of emergency is terminated or the authorization revoked by the agency.
... Thoughts and resources about health, drugs and prescriptions, and how they are affected by GMPs (FDA Good Manufacturing Practices) and other regulations.
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