Check out this article in Genetic Engineering and Biotechnology News, which does a nice job of reviewing some of FDA’s progress and shortcomings in bringing new drugs to market.
They highlight a recent New England Journal of Medicine, which shows how FDA has approved new medicines more quickly than the EMA or Health Canada. The article demonstrates that “there were 510 applications for novel therapeutic agents approved from 2001 through 2010 — 225 by the FDA, 186 by the EMA, and 99 by Health Canada; among the applications, there were 289 unique agents. The median length of time for completion of the first review was 303 days (interquartile range, 185 to 372) for applications approved by the FDA, 366 days (interquartile range, 310 to 445) for those approved by the EMA, and 352 days (interquartile range, 255 to 420) for those approved by Health Canada (P<0.001 for the comparison across the three agencies). “ Other reports that the author notes are the recent California Healthcare Institute (CHI) and The Boston Consulting Group (BCG) report entitled Competitiveness and Regulation: The FDA and the Future of America’s Biomedical Industry and a report issued in March by the U.S. Government Accountability Office (GAO) which are both more critical of the agency’s performance.
For help in navigating FDA’s regulatory requirements, email us at firstname.lastname@example.org.