FDA's financial disclosure plan
WASHINGTON - The FDA has published proposed conflict-of-interest rules mandating financial disclosures by clinical investIgators.
The proposed regulations require that the sponsor of any drug, biological product, or device submit information concerning the compensation to, and financial interests of, any investigator conducting clinical studies to support a marketing application to the agency.
This requirement will apply to most clinical studies involving human subjects, as well as any study to establish bioavailability or bioequivalence.
The agency also proposes to require that