Regulatory Review of Novel Therapeutics — Comparison of Three Regulatory Agencies — NEJM (U.S./Canada/Europe) note references to safety

Regulatory Review of Novel Therapeutics — Comparison of Three Regulatory Agencies — NEJM

"In conclusion, we found that among novel (new) therapeutics approved between 2001 and 2010, the FDA reviewed applications more quickly, on average, than did the EMA and Health Canada, and the vast majority of these novel therapeutics were first approved for use in the United States. Our findings contradict recent criticisms of the speed of review by the FDA and lead to questions about whether the speed of the review process is justified as an emphasis for PDUFA V, particularly since the FDA continues to outpace its European and Canadian peers."