The U.S. Food and Drug Administration today published a guidance document that should help manufacturers develop diagnostic tests for the 2009 H1N1 influenza virus. Although there are not any FDA-approved or cleared tests that diagnose this specific infection, during this pandemic, manufacturers can submit a request to the FDA for an Emergency Use Authorization (EUA)

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FDA Publishes Guidance on Diagnostic Tests for 2009 H1N1 Influenza Virus

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The U.S. Food and Drug Administration today announced it has issued an Emergency Use Authorization (EUA) that allows a 2009 H1N1 influenza virus test to be used to detect the virus in troops serving overseas.

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FDA Authorizes Emergency Use of H1N1 Test for U.S. Troops Serving Overseas

The U.S. Food and Drug Administration today approved the first generic version of the emergency contraceptive Plan B (levonorgestrel) tablets, 0.75 mg

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FDA Approves Generic Prescription-Only Version of Plan B Emergency Contraceptive for Women Ages 17 and Under

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