The final FDA guidance entitled “Guidance for Industry Oversight of Clinical Investigations —A Risk-Based Approach to Monitoring,” issued early August is similar to the draft guidance published in 2011. FDA encourages risk based remote monitoring,...
FDA released a new guidance today that reflects items that have appeared across several past guidance documents. It is entitled “Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Institutional Review Board Responsibilities for...
Check out this intriguing article by Noe Baker in www.biotech-now.org about a new community called Citizen Pscientists. Formed by the Psoriasis Foundation, their hope is to create a community “who are helping impact the future of psoriatic disease...
David Pittman of Medpagetoday.com reports that the Institute of Medicine (IOM) applauded the NIH’s Clinical and Translational Science Awards (CTSA) Program and its significance to the advancement of clinical and translational research. The CTSA program was created to...
FierceBiotechIT.com journalist Ryan Mcbride shares that an alliance with close to 70 organizations has been formed to improve how genomic and clinical data are managed and shared. This alliance is a response to how ineffective big data sharing has been for people...
