FDA guidance
This article was originally published in The Tan Sheet
Executive Summary
Current regs regarding acceptance of foreign clinical studies in support of applications for marketing approval of human drugs remain unchanged despite October revisions to the Declaration of Helsinki undertaken by the World Medical Association, FDA states in a guidance for industry published in March 13 Federal Register. Agency is "reviewing its regulations to determine if it should revise [them] to incorporate new or modified standards or requirements" contained in the declaration, guidance says