The 30-Year Success Story the US FDA Ignored

Yesterday, Senator Bill Cassidy, M.D. (R-LA), chairman of the Senate Health, Education, Labor, and Pensions (HELP) Committee, released a report detailing legislative and regulatory reforms to modernize the Food and Drug Administration (FDA). While many such reports are mere "throat-clearing" exercises, this one proposes a major boon to the U.S. biotech ecosystem: a regulatory structure modeled after Australia’s Clinical Trial Notification (CTN) framework.Australia’s system allows early-stage, in...