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...
After the recent issuing of three final guidance’s by the US FDA, there have been many speculations. Some supporter favor these final documents, while others fear the documents led to the risk of “taking a copycat product.” There are two main groups that reached out...
Single IRB – A Guide to the Common Rule sIRB Mandate
The sIRB requirement is active. Is your study affected?
