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FDA Review Process Speedier than European Counterpart

Posted in News on 4.6.2017

The FDA has been getting flack from the U.S. President as well as the president’s nominee to lead the agency, Dr. Scott Gottlieb, on account of their approvals process, which has been characterized as “slow and burdensome”.

Yet, a recent study published in the New England Journal of Medicine (NEJM) revealed that the FDA approved drugs, more quickly than its European counterpart, the European Medicines Agency (EMA), during the 4-year study period. The median review time of the FDA was 306 days, while the median review time for the EMA was 383 days. 

It appears that the relative speed of the FDA compared with the EMA may be attributed to certain sub-groups of drugs.  While the FDA was speedier at approving drugs for cancer and blood diseases, as well as “orphan drugs” for rare conditions, there was no difference in speed between the two agencies for other drug approvals.  

The information from this study is particularly relevant as lawmakers wrestle with the question of whether to maintain or discard certain FDA regulatory processes.  Read the full article here.