Financial disclosure by clinical investigators--FDA. Final rule; action on petition for reconsideration

Abstract

The Food and Drug Administration (FDA) is revising the requirements regarding financial disclosure by clinical investigators in order to add material to the codified language that was inadvertently omitted and to clarify the compliance dates to, in some cases, restrict the retroactive application of certain requirements of the rule. FDA is making these changes in order to respond to concerns raised by the Pharmaceutical Research Manufacturers Association (hereinafter referred to as "PhRMA"). By making these changes, FDA will be reducing the administrative burden for manufacturers and other affected parties while, at the same time, ensuring that the agency obtains the information that is most relevant to its review of clinical data submitted in marketing applications.