Primer on Regulation of Diagnostic Assays – Essential Points that Pharmaceutical Companies Need to Know Right Now

Historically, pharmaceutical and diagnostic companies in the U.S. have inhabited parallel regulatory universes. Although both sets of firms are overseen by the FDA and are subject to some identical provisions, they have been regulated independently. For the pharma industry, regulatory requirements that apply to in vitro diagnostic (IVD) device manufacturers have been little more than an idle curiosity. That is no longer true.

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