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- Title
FDA: Gene Tests Need Premarket Approval.
- Authors
Kuehn, Bridget M.
- Abstract
The article focuses on the need for manufacturers or marketers of direct-to-consumer gene tests to submit their products for premarketing review and approval by the U.S. Food and Drug Administration (FDA). A series of warning letters was sent by the agency in May and June 2010 to companies covered by the policy indicating a change in the agency's approach to the tests. A greater oversight of the test was called by policy analyst Jesse Reynolds.
- Subjects
UNITED States; HUMAN chromosome abnormality diagnosis; UNITED States. Food &; Drug Administration; MEDICAL equipment; GENETIC testing; REYNOLDS, Jesse; EQUIPMENT &; supplies; GOVERNMENT policy
- Publication
JAMA: Journal of the American Medical Association, 2010, Vol 304, Issue 2, p145
- ISSN
0098-7484
- Publication type
Article
- DOI
10.1001/jama.2010.904