The Four Guidances of the Apocalypse

Mar 24, 2005

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The US Food and Drug Administration's recently released guidance on pharmacogenomic data submissions is an important step in the FDA's evolving ability to obtain, analyze, and, ultimately, approve pharmacogenomics data in drug discovery and development.

The guidance, whose release has been delayed several times since it was unveiled as a draft in November 2003, is actually one of four pharmacogenomics-related guidance documents that the FDA has in various stages of development.

The other three are:

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