Commentary


Nature Biotechnology 24, 927 - 929 (2006)
doi:10.1038/nbt0806-927

A regulatory perspective on in vitro diagnostics

Scott Gottlieb1 & Janet Woodcock1

  1. Scott Gottlieb is Deputy Commissioner for Medical and Scientific Affairs and Janet Woodcock is Deputy Commissioner for Operations, The US Food and Drug Administration, Rockville, Maryland 20857, USA.


A major outreach effort is under way that recruits scientific and technological expertise in industry and academia to optimize regulatory decision-making for next-generation diagnostic tests.

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