While the FDA is preparing to develop and implement a program evaluating the potential use of real-world evidence (RWE) for regulatory decision making, a panel discussion at this year’s DIA Global annual meeting described how the industry is already using RWE to complement clinical trials. Read More

As the January 19 implementation date of the revised Common Rule approaches, the question remains as to whether or not implementation of the revised rule will be delayed — leaving many feeling uncertain. Read More