Day: June 28, 2018

Last week, the Center for Biologics (CBER) announced a new kind of meeting with the FDA reviewers aimed at exploratory discussions prior to initiating significant development work. These meetings are expected to primarily provide an opportunity to discuss the preclinical studies and manufacturing issues related to first-in-human trials with new biological products. These meetings seem very … Read more

The informed consent for any clinical trial requires the sponsor to inform the potential participants about available treatment options outside the trial. For life-threatening indications, it would mean telling the patients that they could get the same investigational drug via the Right-to-Try law without participating in the trial, thereby eliminating the very reason these patients … Read more