UPDATE: FDA Plans Streamlining 510(k) Process in 2011 | GenomeWeb

The story has been updated to include additional comments.

By Matt Jones

NEW YORK (GenomeWeb News) – The US Food and Drug Administration on Wednesday unveiled plan for ways it will try to improve the path to market for medical devices over the coming year.

The 25-point action plan for 2011 is aimed at streamlining the review process, clarifying when clinical data should be submitted, and establishing a new Center Science Council of senior FDA experts to aid in making decisions.

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In Nature this week: genome-wide transcriptome analysis of brain samples from people with autism spectrum disorder, flounder genome, and more.

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