PDUFA DEADLINE IS FOR REAL: CONGRESS WON'T EXTEND SESSION TO FINISH FDA WORK, FDA's SCHULTZ CAUTIONS; SENATE DEBATE BEGINS, CLOTURE OVERRIDES KENNEDY DELAY
Executive Summary
The need to pass a bill to reauthorize the Prescription Drug User Fee Act will not keep Congress in session, FDA Deputy Commissioner for Policy William Schultz pointed out at a Sept. 3 Food & Drug Law Institute meeting in Washington, D.C.