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FDA Wants Harder Approval Standards for Drug-Diagnostic Combos
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. This change will likely necessitate more trials of the diagnostics.
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