ICH seeks to promote integrated quality risk management.

摘要

Some members of Congress and consumer advocates believe it is important to prevent scientists with industry ties from serving on FDA advisory boards. An important FDAAA compromise emphasized the need to reduce conflicts of interest (COIs) among advisors but allowed some waivers so that valuable experts will be able to provide advice when needed. FDA has issued new policies to make COI waiver policies more transparent. The agency is also taking steps to meet Congressional requirements for reducing waivers overall.