FDA REFORM BILL PASSED NOV. 9 EXCLUDES 510(k)s WITH CLINICAL DATA FROM THIRD-PARTY REVIEW; SENATE SUNSET LANGUAGE PLACES IMPLEMENTATION BURDEN ON AGENCY
This article was originally published in The Gray Sheet
Executive Summary
Premarket notification submissions containing clinical data are excluded from the third-party review program in the FDA reform/Prescription Drug User Fee Act reauthorization (S 830) conference bill passed by voice vote by the House and Senate Nov. 9. The exclusion was not in either of the bills passed by the House or the Senate.