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Home » FDA Moving to Make PMA Default Filing for Companion Diagnostics
FDA Moving to Make PMA Default Filing for Companion Diagnostics
June 8, 2012
The FDA is moving toward requiring PMA applications for diagnostics that are paired with specific drugs, rather than the less stringent 510(k) or de novo 510(k) process that are most often used now, said Christine Gathers, senior director of regulatory affairs for Eli Lilly.