FDA REFORM LANGUAGE ENFORCING PMA REVIEW IN 180 DAYS DROPPED FROM FINAL BILL; ANNUAL REPORT PROVISION DOES NOT REQUIRE EXPLANATION OF OVERDUE PMAs
This article was originally published in The Gray Sheet
Executive Summary
Changes to the premarket approval application provisions of FDA reform legislation should ease the pressure to make stricter PMA filing decisions and quicker final actions that the agency had feared it would face under earlier versions of the bill.