The National Academies of Sciences, Engineering and Medicine released a new report in late June that looks at federally funded research and is now recommending an independent commission be established to take a close look at ethical and legal issues of human subjects...
On 6/21/16, the National Institutes of Health (NIH) issued a final policy to streamline IRB review. Expectations are that a single IRB (sIRB) will be used for all non-exempt multi-site research at U.S. sites for research funded by NIH. There may be exceptions only if...
Pearl Pathways is proud to announce that its President and CEO, Diana Caldwell recently completed an elite entrepreneurship training program in the Babson College Cohort of Goldman Sachs’ 10,000 Small Business program. She is among 137 entrepreneurs who graduated in...
Reading an article by Ed Miseta, Clinical Leader, brought to mind the importance of the balance of patient’s needs and scientific advancement. Miseta’s article shared comments from leaders in Pharma where empowered patients and their community voice is recognized and...
The FDA has been working to improve the process used by physicians to request Expanded Access — Compassionate Use to investigational drugs and biologics for their patients who need these therapies to stay alive. In a statement released in early June from FDA...
