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Full-Text Articles in Health Law and Policy

A Liberal Dilemma: Respecting Autonomy While Also Protecting Inchoate Children From Prenatal Substance Abuse., Andrew J. Weisberg, Frank E. Vandervort Mar 2016

A Liberal Dilemma: Respecting Autonomy While Also Protecting Inchoate Children From Prenatal Substance Abuse., Andrew J. Weisberg, Frank E. Vandervort

Articles

Substance abuse is a significant social problem in America. It is estimated that some eighteen million Americans have an alcohol abuse problem and that almost five million have a drug abuse problem. According to the National Institute on Drug Abuse, substance abuse costs some $700 billion per year Substance abuse is a major contributor to child maltreatment. It is estimated that between one- and two-thirds of cases in which children enter foster care are linked to parental substance abuse. Unfortunately, this may be an underestimate as recent research suggests that many cases, particularly cases in which children have been exposed …


Progress In The Fight Against Multidrug Resistant Bacteria?: A Review Of Fda-Approved Antibiotics 2010-2015, Kevin Outterson Jan 2016

Progress In The Fight Against Multidrug Resistant Bacteria?: A Review Of Fda-Approved Antibiotics 2010-2015, Kevin Outterson

Faculty Scholarship

A weak antibiotic pipeline and the increase in drug-resistant pathogens have led to calls for more new antibiotics. Eight new antibiotics were approved by the U.S. Food and Drug Administration (FDA) between January 2010 and December 2015: ceftaroline, fidaxomicin, bedaquiline, dalbavancin, tedizolid, oritavancin, ceftolozane-tazobactam, and ceftazidime-avibactam. This study evaluates the development course and pivotal trials of these antibiotics for their innovativeness, development process, documented patient outcomes, and cost. Data sources were FDA approval packages and databases (January 2010 to December 2015); the Red Book (Truven Health Analytics); Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (FDA); and supplementary information …