Post by lakers on Feb 6, 2016 20:33:06 GMT -5
Regulatory Review of Novel Therapeutics — Comparison of Three Regulatory
The authors reviewed the novel drugs approved between 2001 and 2010 by the FDA, the EMA (Europe) and Health Canada and found that “the FDA has provided more and rapid reviews of applications involving novel therapeutics than have the EMA and Health Canada and that the vast majority of the novel therapeutics first received approval for use in the United States.”
Agencies
www.nejm.org/doi/full/10.1056/NEJMsa1200223#results
The authors reviewed the novel drugs approved between 2001 and 2010 by the FDA, the EMA (Europe) and Health Canada and found that “the FDA has provided more and rapid reviews of applications involving novel therapeutics than have the EMA and Health Canada and that the vast majority of the novel therapeutics first received approval for use in the United States.”
Agencies
www.nejm.org/doi/full/10.1056/NEJMsa1200223#results