If you feel the need for speed, then you perhaps should pursue your new cancer drug approval through the FDA instead of the EMA to get on the market more quickly says a new study. Friends of Cancer Research in studying 23 new cancer drug submissions filed with both agencies found that ALL 23 made it through the FDA first. The FDA took only half the time too -- 350 days in EMA versus half that at FDA.
FDA Commissioner Margaret Hamburg said that the study "reflects FDA's commitment to foster access to effective therapies in a responsive and timely manner." See Fierce Biotech.
Posted by Bruce Lehr June 16th 2011.