Califf: Nothing Prohibits FDA From Using Real-World Evidence In Decisions

FDA will release a series of documents on its proposed real-world evidence system over the next several months, and Rachel Sherman, deputy commissioner for medical products and tobacco, signaled the agency is bracing for potential pushback from some stakeholders. Commissioner Robert Califf stressed that real-world evidence and randomized clinical trials are intertwined, and said nothing prohibits the use of real-world evidence data in regulatory decisions. “[T]here’s nothing in current FDA regulations or guidance about the so-called evidence standard,” Califf said...