Harmonization By Doing (HBD)

Harmonization By Doing (HBD): A look to the future

Co-sponsored by the U.S. Food and Drug Administration (FDA), the Center for Devices and Radiological
Health and Duke University (Duke), the Duke Clinical Research Institute (DCRI), and the Advanced Medical
Technology Association (AdvaMed)


It has been over 5 years since HBD was established as a cooperative effort between Japan and the United States toward regulatory harmonization. Since its initial meeting in December of 2003, there have been numerous think-tank style meetings in both the US and Japan attended by representatives from FDA, MHLW, academia and the industry.