GAO ESTIMATES EUROPEAN DRUG REVIEWS OF 298-448 DAYS UNDER NEW SYSTEM; FDA CALLS REPORT EVIDENCE AGAINST SIX-MONTH DEADLINE IN AGENCY REFORM LEGISLATION
Executive Summary
European-wide approval of new drugs and biologics under centralized EMEA review "is expected to take between 298 and 448 days," according to a GAO report on European Union drug approval issued April 5.