Search results
Results From The WOW.Com Content Network
t. e. The Drug Price Competition and Patent Term Restoration Act (Public Law 98-417), informally known as the Hatch-Waxman Act, is a 1984 United States federal law that established the modern system of generic drug regulation in the United States. The Act's two main goals are to facilitate entry of generic drugs into the market and to ...
United States, No. 20-1410 , 597 U.S. ___ (2022) The Controlled Substances Act ( CSA) is the statute establishing federal U.S. drug policy under which the manufacture, importation, possession, use, and distribution of certain substances is regulated. It was passed by the 91st United States Congress as Title II of the Comprehensive Drug Abuse ...
The 1906 Pure Food and Drug Act and creation of the FDA. In June 1906, President Theodore Roosevelt signed into law the Pure Food and Drug Act, also known as the "Wiley Act" after its chief advocate. [1] The Act prohibited, under penalty of seizure of goods, the interstate transport of food which had been "adulterated," with that term referring ...
The U.S. Kefauver–Harris Amendment or "Drug Efficacy Amendment" is a 1962 amendment to the Federal Food, Drug, and Cosmetic Act. It introduced a requirement for drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval, required drug advertising to disclose accurate information about side effects, and stopped cheap generic drugs being marketed as ...
A generic drug (or simply generic) is a pharmaceutical drug that contains the same chemical substance as a drug that was originally protected by chemical patents. Generic drugs are allowed for sale after the patents on the original drugs expire. Because the active chemical substance is the same, the medical profile of generics is equivalent in ...
An Abbreviated New Drug Application ( ANDA) is an application for a U.S. generic drug approval for an existing licensed medication or approved drug . The ANDA is submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, which provides for the review and ultimate approval of a generic drug product.
An act to prohibit discrimination on the basis of genetic information with respect to health insurance and employment. The Genetic Information Nondiscrimination Act of 2008 ( Pub. L. 110–233 (text) (PDF), 122 Stat. 881, enacted May 21, 2008, GINA / ˈdʒiː.nə / JEE-nə ), is an Act of Congress in the United States designed to prohibit some ...
The Pure Food and Drug Act of 1906, also known as the Wiley Act and Dr. Wiley 's Law, was the first of a series of significant consumer protection laws enacted by the United States Congress, and led to the creation of the Food and Drug Administration (FDA). Its main purpose was to ban foreign and interstate traffic in adulterated or mislabeled ...