Recent comments from FDA officials and industry leaders suggest a shift in the conceptualization of what constitutes reliable clinical research. Data used to make regulatory decisions may soon be pulled from non-traditional data sources outside of standard clinical...
There is still time to register for the ACRP Circle City Chapter 17th Annual Fall Symposium occurring next Monday September 25, 2017. The symposium, titled “Excellence in Clinical Research 2017: Strategies to become a Great Site” will take place at the...
FDA commissioner Scott Gottlieb plans to close a loophole currently allowing companies to avoid their obligation to study pharmaceuticals in pediatric populations. Gottlieb plans to close the loophole currently impacting pediatric clinical trials through a new...
The NIH-FDA Joint Leadership Council and TransCelerate BioPharma released updated common protocol templates (CPT) last week to accelerate clinical development. An Outsourcing-Pharma.com article and interview with TransCelerate CEO, Dalvir Gill, details some of the key...
The historic 21st Century Cures Act, written into law last December, is a 362-page bill comprised of several initiatives impacting the life sciences industry. The allocation of $4.8 billion for the “Cancer Moonshot” portion of the bill won over most headlines during...
America prides itself as a leader in technological innovation and medical research. Home to some of the largest and well respected cancer centers in the world, the U.S. has stood as the epicenter for cancer research for several decades. If the U.S. wishes to retain...
