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...
Beginning September, 2017, the National Institutes of Health (NIH) will require that a single IRB (sIRB) of record be used in the ethical review for all NIH-funded non-exempt, multi-site human subjects research protocols in the United States (NOT-OD-16-094). The sIRB...
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...
The Government Accountability Office (GAO) recently released a report in regard to women in clinical research. While past efforts by the National Institutes of Health (NIH) have increased the number of women involved in research, further changes are still necessary....
The 21st Century Cares Act was passed with an overwhelming majority on July 10th, 2015. This bill would increase the funding for both the NIH and FDA and instate a new framework for evaluating patience’s experience with drugs risks and benefits. Not only will the bill...
