Comment from Pharmaceutical Research and Manufacturers of America (PhRMA)

Summary: PhRMA, representing leading biopharmaceutical research companies, supports the FDA's draft guidance on protocol deviations but requests several specific revisions. They argue for better alignment with International Council for Harmonisation (ICH) guidelines, a shift in focus from reporting "all" deviations to "all important" deviations, and clarifications on reporting timelines and data standards.