#516: Operation Trailblazer: HHS Moves To Accelerate Drug Development As China Gains Ground, & More

Last month, the U.S. Department of Health and Human Services (HHS) announced Operation Trailblazer, including a coordinated package of reforms to the U.S. Food and Drug Administration's (FDA’s) Investigational New Drug (IND) application process, intended to reduce the time and cost required to initiate first-in-human clinical trials. The announcement comes amid significant erosion in the US’ share of early-stage pharmaceutical development, thanks largely to deregulation in China over the past few years. According to HHS, its reforms could reduce early stage development timelines by 6 to 12 months.