Browsing Harvard Law School by Keyword "drug regulation"
Now showing items 1-4 of 4
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A History of Accelerated Approval: Overcoming the FDA's Bureaucratic Barriers in order to Expedite Desperately Needed Drugs to Critically Ill Patients
(2005)After the passage in 1962 of the Kefauver-Harris Drug Amendments that mandated that the FDA grant premarket approval for all drugs and added a requirement that drug manufacturers demonstrate the efficacy of their products, ... -
Ideals and Issues From a Critical View of the Supreme Court’s Jurisprudence in FDA Regulation of Human Drugs
(2003)Since Congress first enacted an extensive regulatory regime for human drugs in 1906 with the Pure Food and Drug Act, the Supreme Court has shaped the contours of federal drug regulation with a variety of legal doctrines ... -
THE PERVASIVELY REGULATED BUSINESS EXCEPTION AND THE FDA
(1995)Section 704 of the Federal Food, Drug and Cosmetic Act authorizes the Food and Drug Administration to conduct inspections of regulated business establishments. In the statute. Congress required that the inspections be at ... -
Toward Rational Regulation of Marijuana in the United States: FDA's Role in Consumer Choice and Safety
(1995)The Food and Drug Administration is an agency dedicated to maintaining the health and safety of the American public. For as long as people have been purchasing and consuming foods and drugs there have been the problems of ...