Financial Disclosure by Clinical Investigators; Public Hearing

Streszczenie

The Food and Drug Administration (FDA) is announcing a public hearing regarding a proposed regulation that would require disclosure of certain financial interests and arrangements by clinical investigators. The proposed regulation would require that sponsors submitting clinical studies in support of marketing applications for human drugs, biologics, and medical devices either certify to the absence of certain financial interests of clinical investigators or disclose those financial interests. The purpose of the public hearing is to obtain additional comments and information on specific issues for use in developing a final rule, and a proposed rule to extend these requirements to submissions for marketing approval related to human foods, animal foods, and animal drugs. The public hearing will address specific issues on which FDA seeks information and comment, and time will also be set aside after these issues have been addressed during which participants will have an opportunity to address other aspects of the proposed regulation.