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Full-Text Articles in Law
Interpreting Biological Similarity: Ongoing Challenges For Diverse Decision Makers, Sarah M. Cork
Interpreting Biological Similarity: Ongoing Challenges For Diverse Decision Makers, Sarah M. Cork
Michigan Telecommunications & Technology Law Review
Similarity is an elusive and complicated concept facing comparisons of biological molecules, as even minute changes to a molecule's structure can dramatically affect its function in the body. Yet the flood of biologic drugs on the market will increasingly force these similarity comparisons. These concerns are particularly relevant to two groups of drugs: families of biologic drugs that closely resemble each other in structure and function, here termed "similar-impact biologics," and the biosimilars, which are intended to closely approximate generic forms of biologic drugs. In bringing biologic drugs to the market, manufacturers are likely to face dual obstacles: FDA approval …
Congress Underestimated: The Case Of The World Bank, Kristina Daugirdas
Congress Underestimated: The Case Of The World Bank, Kristina Daugirdas
Articles
This article challenges the oft-repeated claim that international organizations undermine democracy by marginalizing national legislatures. Over the past forty years, Congress has established itself as a key player in setting U.S. policy toward the World Bank. Congress has done far more than restrain executive branch action with which it disagrees; it has affirmatively shaped the United States’ day-to-day participation in this key international organization and successfully defended its constitutional authority to do so.