Lawyers: FDA RWE Guide Is A Big First Step, But Challenges Remain

A drug industry lawyer and a drug regulation expert applauded a recent FDA draft guidance on the use of real-world evidence (RWE) and real-world data (RWD) in drug and biologics applications as a major step forward, but said questions remain related to data quality and informed consent. The guidance, experts say, takes the first step in making RWE a valid form of evidence of effectiveness, which sponsors can use to help get their drugs or biologics approved. The guidance, which...