The FDA is slow? Not so fast!

Doctors and patients who are impatient for new drugs to hit the market often get the sense that the United States’ drug approval process is a long and slow road. But a new study by School of Medicine researchers found that the U.S. Food and Drug Administration (FDA) actually moves faster when reviewing drug applications than its counterparts in Canada and Europe.

The first author of the study, third-year Yale medical student Nicholas Downing, and a team led by Assistant Professor of Internal Medicine Joseph S. Ross, M.D., M.H.S., examined publically available drug applications from 2001 through 2010 to the FDA, the European Medicines Agency (EMA), and Health Canada.

As reported May 16 in the New England Journal of Medicine, for 72 drugs eventually approved by all three agencies, the average review time at the FDA was 90 to 100 days faster than at the other agencies, and most of these drugs hit the U.S. market first. For all drugs reviewed during the nine-year period, the FDA took 322 days on average, while the EMA averaged 366 days and Health Canada took 393 days.


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