The U.S. Food and Drug Administration (FDA) establishes rules by drafting, modifying, and publishing through draft guidance. “By law, anyone can participate in the rule-making process by commenting in writing. FDA routinely allows plenty of time for public input (typically 60 days) and carefully considers these comments when it draws up a final rule. The public can submit comments about the proposed regulation directly to the agency (through the mail or online at www.regulations.gov).”^[1]

Recently, the FDA asked for Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products. With a deadline in early May, the draft guidance document provided recommendations for the design and conduct of externally controlled trials, including discussions on the validity of a trial without bias.