The New Drug Lag: EU Lags in Review Times of Monoclonal Antibodies

FDA had been criticized for its slow review of new drugs. Critics complained of a “drug lag” from which US patients suffered when compared to Europeans. Since the advent of PDUFA, however, the FDA has demonstrated a possible slight advantage in review time when compared to the EMA. Submission and approval dates for monoclonal antibodies were collected from the FDA and EMA websites. When using monoclonal antibodies as examples of complex, yet...