CDRH WOULD DESIGNATE STAFFER TO SPEED SUPPLEMENT REVIEWS UNDER KENNEDY AMENDMENT ADOPTED AT MARK-UP; THIRD-PARTY REVIEW LANGUAGE UNCHANGED
This article was originally published in The Gray Sheet
Executive Summary
FDA's device, drug, biologics and veterinary medicine centers each would be required to designate a staffer responsible for expediting supplemental applications for approved products under an amendment by Sen. Edward Kennedy (D-Mass.) incorporated into the Senate FDA reform bill (S 830) during June 18 mark-up by the Senate Labor and Human Resources Committee.