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Full-Text Articles in Law
Drug Development--Stuck In A State Of Puberty?: Regulatory Reform Of Human Clinical Research To Raise Responsiveness To The Reality Of Human Variability, Michael J. Malinowski
Drug Development--Stuck In A State Of Puberty?: Regulatory Reform Of Human Clinical Research To Raise Responsiveness To The Reality Of Human Variability, Michael J. Malinowski
Journal Articles
Scathing critiques of the Food and Drug Administration's (“FDA”) performance by the Government Accountability Office and Institutes of Medicine, a plummet in innovative new drug approvals in spite of significant annual investment increases in biopharmaceutical research and development (“R&D”), and market controversies such as the painkiller Vioxx and the diabetes drug Avandia (both associated with significantly escalated risks of heart attacks and strokes) have raised doubts about the sufficiency of FDA *364 regulation. This Article questions how prescription medicines reach the market and proposes law-policy reforms to enhance the FDA's science standard for human clinical trials and new drug approvals. …