Evolving Regulatory Environment

Advocacy and Policy

Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics Guidance for Industry

Developing Real-World Data and Evidence to Support Regulatory Decision-Making

Framework for FDA’s Real-World Evidence Program

Accelerating development of scientific evidence for medical products within the existing US regulatory framework

How FDA, Pfizer, and Flatiron Health did itApproval of Ibrance for men affords a glance at use of real world data

FDA cancer office taps Syapse for real-world evidence development

Pivotal Study Validates Real-World Mortality Endpoint for Oncology Research

Congress passes 21st Century Cures Act, boosting research and easing drug approvals