The National Pharmaceutical Council (NPC) says the Food and Drug Administration’s (FDA) recent real-world evidence framework is a step in the right direction.
The FDA released the framework Thursday, Dec. 6, and lays out how the federal agency will assess potential uses for RWE in drug approvals.
“We’re pleased to see the FDA move forward with its efforts to harness real-world data,” NPC Vice President for Comparative Effectiveness Research Jennifer Graff says. “Understanding how treatments work in the real world is an important and complex task to guide the appropriate use of biopharmaceuticals available for typical patients in real-world clinical practice environments.”
To read the FDA’s new framework, click here.