PhRMA DEFAULT MECHANISM FOR EMEA/U.K. APPROVED DRUGS FOLDED INTO "ACCELERATED APPROVAL" PROCESS IN FDA REFORM PROPOSAL DRAFTED BY SENATE LABOR COMMITTEE
Executive Summary
NDAs for drugs to treat serious or life-threatening conditions that already have been approved by the European Medicines Evaluation Agency or the U.K. Medicines Control Agency would be eligible for a "fast track process" for FDA review under Senate Labor & Human Resources Committee Chairman Kassebaum's (R-Kan.) FDA reform concept paper being circulated the week of Aug. 7.