FDA
Paul Gouge, J.D. is a Regulatory Counsel working in the Center for Drug Evaluation and Research Office of Medical Policy. In this capacity he has acted as the technical lead for the recently published draft guidances: Frequently Asked Questions Statement of Investigator (Form FDA 1572); Sponsor Responsibilities — Safety Reporting Requirements and Safety Assessment for IND and Bioavailability (BA)/Bioequivalence Studies (BE); and Investigator Responsibilities--Safety Reporting for Investigational Drugs and Devices.
Disclosure information not submitted.