FDA Wants Harder Approval Standards for Drug-Device Combo Diagnostics

Pharma companies seeking approval for drugs along with companion diagnostics could see more streamlined FDA decisions as the agency moves toward a stricter preapproval path for the diagnostic portion of companion products. The FDA is moving toward requiring premarket approval (PMA) applications for companion diagnostics, rather than the less stringent 510(k) or de novo 510(k) applications that are most often used now, said Christine Gathers, senior director of regulatory affairs for Eli Lilly.
Washington Drug Letter