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Comment On Regulation Of Innovative Diagnostic Tests By January 5th

Wednesday, December 17, 2014  
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The House Energy and Commerce Committee has released its latest white paper in the 21st Century Cures initiative. The paper solicits feedback regarding the regulation of in vitro diagnostic test kits and laboratory developed tests. All comments can be sent to by January 5, 2015.

The paper explains, “The committee understands that FDA’s approach has led to a number of important questions about administrative process and policy. In addition to questions about the framework proposed, we are aware that the agency’s release of the guidance documents has served as a catalyst for broader conversations about the overarching need to modernize governmental oversight of these unique and increasingly important medical products. As the 21st Century Cures initiative proceeds, with preparations for a discussion draft early in the New Year, the committee appreciates all interested stakeholders’ specific feedback on the following questions by January 5, 2015, in addition to advice on what role Congress should play in addressing any other related issues.”

Read the complete paper online here.

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