We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
Home » FDA Wants Harder Approval Standards for Drug-Diagnostic Combos
FDA Wants Harder Approval Standards for Drug-Diagnostic Combos
June 20, 2012
The FDA is moving toward requiring premarket approval applications (PMAs) for diagnostics that are paired with specific drugs, rather than the less stringent 510(k) or de novo 510(k) pathways that are most often used now, said Christine Gathers, senior director of regulatory affairs for Eli Lilly.