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Full-Text Articles in Law
Globalization Of Biotechnology And The Public Health Challenges Accompanying It, Michael J. Malinowski
Globalization Of Biotechnology And The Public Health Challenges Accompanying It, Michael J. Malinowski
Michael J. Malinowski
No abstract provided.
Commercialization Of Genetic Testing Services: The Fda, Market Forces, And Biological Tarot Cards, Michael J. Malinowski, Robin J.R. Blatt
Commercialization Of Genetic Testing Services: The Fda, Market Forces, And Biological Tarot Cards, Michael J. Malinowski, Robin J.R. Blatt
Michael J. Malinowski
No abstract provided.
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
Michael J. Malinowski
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. …
Government Rx--Back To The Future In Science Funding? The Next Era In Drug Development, Michael J. Malinowski
Government Rx--Back To The Future In Science Funding? The Next Era In Drug Development, Michael J. Malinowski
Michael J. Malinowski
The roles of government, industry, and academia in science research have been recast repeatedly since the U.S. began infusing tremendous funding during WWII. Recently, the National Institutes of Health (NIH) proposed a billion-dollar center to intervene in commercial drug development with the objective of lifting it out of a frightening fifteen-year slump in productivity. This article questions the role of the U.S. government in pharmaceutical development after completion of a map of the human genome (the touchstone of the Human Genome Project, HGP), a research undertaking spearheaded by the U.S. Government that spanned more than a decade. Specifically, the article …