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With respect to regulation, two terms are defined: Postmarketing requirements are studies and clinical trials that sponsors are required to conduct and postmarketing commitments are studies or clinical trials that a sponsor has agreed to conduct, but that are not required by a statue or regulation. [10]
United States v. Comstock, 560 U.S. 126 (2010), was a decision by the Supreme Court of the United States, which held that the federal government has authority under the Necessary and Proper Clause to require the civil commitment of individuals already in Federal custody. [1]
A new drug application in the 1930s for sulfapyridine to the United States Food and Drug Administration. The Food and Drug Administration's (FDA) New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing.
Offer and acceptance are generally recognized as essential requirements for the formation of a contract (together with other requirements such as consideration and legal capacity). Analysis of their operation is a traditional approach in contract law .
A Law Reference Collection, 2011, ISBN 1624680003 and ISBN 978-1-62468-000-7; Trinxet, Salvador. Trinxet Reverse Dictionary of Legal Abbreviations and Acronyms, 2011, ISBN 1624680011 and ISBN 978-1-62468-001-4. Raistrick, Donald. Index to Legal Citations and Abbreviations. 3rd ed. London: Sweet & Maxwell, 2008. This book focuses more on British ...
Supporters of direct-to-consumer advertising argue that advertisements increase competition which leads to lower prescription drug prices and new development, citing, for instance, that between 1997 and 2001, spending on research and development in the U.S. increased 59% while spending on promoting drugs directly to patients increased 145%.
The FDA animal efficacy rule (also known as animal rule) applies to development and testing of drugs and biologicals to reduce or prevent serious or life-threatening conditions caused by exposure to lethal or permanently disabling toxic agents (chemical, biological, radiological, or nuclear substances), where human efficacy trials are not feasible or ethical. [1]
The law of contracts varies from state to state; there is nationwide federal contract law in certain areas, such as contracts entered into pursuant to Federal Reclamation Law. The law governing transactions involving the sale of goods has become highly standardized nationwide through widespread adoption of the Uniform Commercial Code .