Standardization of genetic tests needed
- PATENT-MEDIATED STANDARDS IN GENETIC TESTING. Kane, Eileen M. // Utah Law Review;2008, Vol. 2008 Issue 3, p835
Genetic testing can be used to identify disease susceptibility, establish diagnostic status, and design therapeutic regimens in medical care. Two legal realities shape the genetic testing environment in the United States. First, most genetic tests are not subject to premarket review by the Food...
- FDA reopens DTC gene test comment period. // Medical Device Daily;4/8/2011, Vol. 15 Issue 68, p7
The article reports on the decision of the U.S. Food and Drug Administration (FDA) to reopen the comment period for its proposal to implement regulatory requirements on companies that are offering direct-to-consumer genetic tests in April 2011.
- FDA resists regulatory role in gene tests. Wadman, Meredith // Nature;11/14/1996, Vol. 384 Issue 6605, p101
Discusses the controversy surrounding the decision by a government-sponsered task force to recommend that the US Food and Drug Administration (FDA) regulate genetic tests. The task force comprised of the National Institutes of Health and the Department of Energy Task Force on Genetic Testing;...
- 'Genetic Exceptionalism' in Medicine: Clarifying the Differences between Genetic and Nongenetic Tests. Green, Michael J.; Botkin, Jeffrey R. // Annals of Internal Medicine;4/1/2003, Vol. 138 Issue 7, p571
Examines arguments related to predictive genetic testing, the testing of asymptomatic persons for future health problems. Common factors among genetic and nongenetic predictive tests; Claims regarding the need for special treatment of genetic predictive test; Suggestions to physicians.
- FDA CLEARS FIRST GENETIC LAB TEST. // Materials Management in Health Care;Feb2005, Vol. 14 Issue 2, p7
This article reports that the U.S. Food and Drug Administration (FDA) has cleared a new product for market that purports to make determining the right medication and dosage a little easier for patients with certain conditions. The AmliChip CYP450 Test, manufactured by Roche, Indianapolis, allows...
- THE OPTIMAL SCOPE OF FDA REGULATION OF GENETIC TESTS: MEETING CHALLENGES AND KEEPING PROMISES. Han, Juliana // Harvard Journal of Law & Technology;Spring2007, Vol. 20 Issue 2, p423
The article discusses the trends in genetic tests and the current regulatory framework for such tests in the U.S. and explores the constitutional and statutory sources of authority for the U.S. Food and Drug Administration (FDA) oversight of laboratory-developed genetic tests. Unlike genetic...
- Messing with home brews. // Nature Biotechnology;Mar2007, Vol. 25 Issue 3, p262
Political moves to expand FDA oversight to home brews are a bad idea.
- PRODUCT BRIEFS. // Diagnostics & Imaging Week;11/13/2008, Vol. 11 Issue 46, p12
This section offers news briefs related to the medicine industry as of November 2008. During the American Society of Nephrology's Renal Week, presentations showed that frequently monitoring hemoglobin during hemodialysis will give physicians information that may lessen hemoglobin variability....
- Gene Tests Under Fire. J. W. // Pharmaceutical Executive;Oct2006, Vol. 26 Issue 10, p22
The article reports on the move of the Food and Drug Administration to shift high technology genetic testing methods under its regulatory umbrella in the U.S. The agency currently regulates diagnostics and tests sold by manufacturers to doctors and hospitals. It is noted that a draft guidance...