Helpful Resources
Real-World Evidence: What is the Big Deal with the FDA’s New RWE Program ?
The FDA’s recent framework for the use of Real World Evidence allows the collection of data in the “real world” to be used in FDA submissions. However, this framework fails to address how this data can impact your research and approvals, leaving many drug
Does Your CRO Really Know the FDA?
Any mishaps or misunderstandings will cost your organization tens of millions of dollars in additional development time. That doesn’t even include what you’re going to lose when it comes to delaying your time to market.
One Bad CRO Stat Can Sink Your FDA Approval
Accuracy is especially important in today’s environment. In fact, a JAMA study of the years 2000-2012 shows that over 40% of drugs rejected by the FDA were due to poorly conducted research.