Financial Disclosure by Clinical Investigators; Reopening of Comment Period and Notice of Meeting

概要

The Science Board to the Food and Drug Administration (FDA), an FDA advisory committee, will hold an open committee meeting to discuss the proposed rulemaking on Financial Disclosure by Clinical Investigators, which published in the Federal Register of September 22, 1994. At the same time, FDA is reopening the comment period for the proposed rule. The proposed rule would require that the sponsor of any drug, biological product, or device submit certain information concerning the compensation to, and financial interests of, any clinical investigator conducting clinical studies to determine whether that product meets the marketing requirements specified by the agency. FDA is taking these actions in order to obtain additional comment on whether the provision on``significant payments of other sorts'' should be eliminated from the proposed rule.