To America's Health: A Proposal to Reform the Food and Drug Administration

1999 Industry Profile Accredited Persons Advancing Medical Innovation agency's breast implants changes clinical testing clinical trials Competitive Enterprise Institute Congress costs DCB's DCBs decisions disease Drug Administration Drug Application drug approval drug companies drug development Drug Information Journal drug manufacturers drug regulation drug review drug sponsor Drugs and Biologics efficient EMEA Enterprise Institute evaluation example experts FDA's FDAMA Food and Drug hepatitis improve Industry Profile Washington legislation liability licensing Louis Lasagna Manufacturers of America marketing approval medical devices Miller nongovernmental NRTLs number of patients off-label organizations oversight percent performed Pharmaceutical Research phase PhRMA preclinical premarket approval proposed public health recommendation regulatory agencies regulatory reform reporting research and development Research and Manufacturers responsibility risk safety and effectiveness safety and efficacy side effects standards statute studies surrogate end points therapeutic therapy tion Tufts University type 2 errors Underwriters Laboratories United Kingdom vaccine Washington D.C.