Nature Biotechnology
- 24, 927 - 929 (2006)
doi:10.1038/nbt0806-927
A regulatory perspective on in vitro diagnosticsScott Gottlieb & Janet Woodcock
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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