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FDA Publishes Guidance Document for H1N1 Dx

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Published at: www.genomeweb.com

Ken Powell, President

Ken PowellPresidentGenesis Business Development, LLC What is a GLG Leader?|The Gerson Lehrman Group&reg; (GLG) Leader Program<sup>SM</sup> is our premium Member Program<sup>SM</sup>. Those identified as GLG Leaders are in the top 5% of GLG CouncilRank and have an exclusivity agreement with GLG.

FDA Publishes H1N1 Diagnostic Test Guidance

November 5, 2009

The FDA published document designed to help diagnostic test manufactures develop H1N1 tests and data that would accompany a FDA application to market them.  This follows on the recent issuance of CDC guidelines for H1N1 tests.

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