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- Title
A regulatory perspective on in vitro diagnostics.
- Authors
Gottlieb, Scott; Woodcock, Janet
- Abstract
The article reports that the U.S. FDA has initiated efforts to employ the knowledge of experts in industry and academia to better enable it to make regulatory decisions around new diagnostic tests. The FDA regulates IVD devices in accordance with the device provisions of the US Federal Food, Drug and Cosmetic Act. One of the most efficient approaches would be to create a drug and the corresponding diagnostic test during the same development program.
- Subjects
UNITED States; DIAGNOSIS; UNITED States. Food &; Drug Administration; DECISION making; GOVERNMENT agencies; PHARMACEUTICAL industry
- Publication
Nature Biotechnology, 2006, Vol 24, Issue 8, p927
- ISSN
1087-0156
- Publication type
Editorial
- DOI
10.1038/nbt0806-927