Regulatory Update

Posted 01 August 2011 | By Michael Matthews 

The Food and Drug Administration (FDA) understands the potential importance of companion diagnostics in the future of personalized medicine. Although a few companion diagnostics have been approved, there are many more in development. Therapeutics that depend upon the use of in vitro diagnostic (IVD) tests have unique regulatory requirements. FDA released a draft guidance to assist sponsors in the development of IVD companion diagnostics.

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