Linda Charles

New FDA commissioner plans to apply clinical trials insights gained at Duke


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Today's blog is from Sathya Ganesan, Ph.D., RAC:

Lab Coat and Beyond

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By Rachel A. Hardy, MA, RAC

The federal Department of Health and Human Services encompasses many agencies, each promulgating its own sets of regulations. At times, these regulations appear to contradict one another. On 7 April 2014, a rule issued by the Center for Medicare and Medicaid Services, the Centers for Disease Control and Prevention, and the Office of Civil Rights modified the CLIA (Clinical Laboratory Improvement Amendments) regulations to allow laboratories subject to CLIA to provide patients “with copies of completed test reports” (DHHS, 2014, p. 7290).

Late last year, the Food and Drug Administration issued a warning letter to the company 23andMe for not obtaining marketing clearance or approval for the 23andMe Saliva Collection Kit and Personal Genome Service (PGS). It stated “assessments for drug responses carry the risks that patients relying on such tests may begin to self-manage their treatments through dose changes or even abandon certain therapies depending on the outcome of the assessment. … Serious concerns are raised if test results are not adequately understood by patients or if incorrect test results are reported” (FDA 2013a).

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