FDA Publishes Guidance Document for H1N1 Dx | GenomeWeb

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has published a guidance document intended to help manufacturers develop diagnostic tests for the 2009 H1N1 influenza virus.

The FDA said that it "recognizes that it may not be possible to generate complete clinical validation data that would normally be included in an application," but the guidance document outlines the information that the agency believes should be included in an application for marketing.

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