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Full-Text Articles in Legislation
Pdufa And Initial U.S. Drug Launches, Mary K. Olson
Pdufa And Initial U.S. Drug Launches, Mary K. Olson
Michigan Telecommunications & Technology Law Review
In the 1970s and 1980s, many pharmaceutical firms launched new drugs abroad prior to gaining U.S. approval. Consequently, U.S. patients often faced delays in accessing important new medicines. High regulatory barriers to entry, such as a stringent regulation and a lengthy drug review process, contributed to this problem. This Article examines the impact of the Prescription Drug User Fee Act (PDUFA), and subsequent increases in the speed of FDA review, on the likelihood of initial U.S. drug launches. These factors are hypothesized to lower regulatory barriers to entry in the U.S. pharmaceutical market. The results show that increased drug review …
Pursuing The Perfect Mother: Why America's Criminalization Of Maternal Substance Abuse Is Not The Answer- A Compartive Legal Analysis, Linda C. Fentiman
Pursuing The Perfect Mother: Why America's Criminalization Of Maternal Substance Abuse Is Not The Answer- A Compartive Legal Analysis, Linda C. Fentiman
Michigan Journal of Gender & Law
In this Article the author will examine not only the substantive legal differences between the United States, Canada, and France, but will also explore how these legal rules fit within a broader social, political, and religious setting. This Article will pursue four lines of inquiry. First, it will briefly chronicle the history of criminal prosecution of pregnant women in America and show how these prosecutions have become markedly more aggressive over the last twenty years. Second, it will situate these prosecutions in the full context of American law and culture, demonstrating how the fetus has received increasing legal recognition in …