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YOUR GO-TO SOURCE FOR ANALYSIS OF ISSUES AFFECTING THE PHARMA & BIOTECH SECTORS
FDA recently released the framework for its Real World Evidence (RWE) program, educating stakeholders about the agency’s approach to RWE when making efficacy decisions. The document is notable more for its discussion of the limitations rather than the potential for RWE. Although FDA plans to issue a number of RWE guidance documents and conduct RWE stakeholder events, the path to routine use of RWE looks to be a long and winding one.