Guidance for Industry on Financial Disclosure by Clinical Investigators; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Financial Disclosure by Clinical Investigators." FDA published a final rule requiring anyone who submits a marketing application for any drug, biologic, or device to submit certain information concerning the compensation to, and financial interests of, any clinical investigator conducting clinical studies covered by the rule. These requirements took effect on February 2, 1999. This guidance is intended to provide clarification and respond to questions and comments concerning implementation of the final rule.