Financial Disclosure: CFR Part 54 vs. The Sunshine Act

By Nicole Mooney

The financial disclosure collection requirements under 21 CFR Part 54 have long been a major aspect of the initiation and study conduct of covered clinical studies. However, the newly released Physician Payments Sunshine Act aka “Sunshine Act” and “Open Payments” has shed some light on areas that were not always considered. Looking closely into these regulations, I found similarities between the two as well as some major differences.