The U.S. Food and Drug Administration (FDA) just issued a call to industry and other interested parties to weigh in on an important draft guidance, “E8(R1) General Considerations for Clinical Studies.”
If you have the pleasure of knowing me in the professional world, or perhaps sitting through one of my lectures, you’re all too familiar with what I have to say […]
With Australian specialty pharmaceutical company Race Oncology’s announcement last week that the first patient had been treated with the “lost” drug Bisantrene in a clinical trial for relapsed/refractory acute myeloid […]
There’s no “silver bullet" or “holy grail” when it comes to juggling complex, multi-center clinical trials, says Samantha Sharpe, CCRP, Program Manager, Nationwide Children’s Hospital: Abigail Wexner Research Institute. “There’s […]
Calling out clinical trials as the “most expensive part of drug discovery and development,” Acting U.S. Food and Drug Administration (FDA) Commissioner Dr. Ned Sharpless just told agency staff he’s […]