Webinar: Genetic Testing in a Changing Regulatory Landscape
Source
Genetic Alliance webinars
Description
Genetic diagnostic tests are playing an increasingly important role in clinical practice. The Food and Drug Administration (FDA) regulates in vitro diagnostic tests that are sold by manufacturers for use in diagnostic medicine. Many diagnostic tests are currently offered as laboratory developed tests, which are not regulated by FDA. The FDA's regulation of diagnostic devices has a significant impact on the availability of new diagnostic assays. The FDA is also starting to regulate some laboratory developed tests. This webinar discusses the latest developments in FDA regulation of in vitro diagnostic tests, and the potential impact of these regulatory initiatives on access to diagnostic tests, including genetic tests.Presenters:
Jeffrey Gibbs - Director, Hyman, Phelps & McNamara, P.C. [PowerPoint Presentation]
Paul Radensky - Partner, McDermott Will & Emery LLP [PowerPoint Presentation
Date Added
September 29, 2009
Keywords
Hot Topics in Genetics and Advocacy, genetic testing,
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