Submitting Documents Using Real-World Data and Real-World Evidence to the Food and Drug Administration for Drugs and Biologics

As part of its advocacy program in the United States, ACRO submits regulatory comments to US regulators. This comment letter, submitted by ACRO to FDA in 2019 about Submitting Documents Using Real-World Data and Real-World Evidence to the Food and Drug Administration for Drugs and Biologics can be found below.