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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 compensate the ...
Signed into law by President John F. Kennedy on October 10, 1962. 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, [ 1][ 2 ...
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 Prevention and Control Act of 1970 and signed into ...
Signed into law by President Harry S. Truman on October 26, 1951. The Durham–Humphrey Amendment explicitly defined two specific categories for medications, legend ( prescription) and over-the-counter (OTC). This amendment was co-sponsored by then Senator (and later Vice President) Hubert H. Humphrey Jr., who was a pharmacist in South Dakota ...
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 ...
II § 951 et seq. The Anti-Drug Abuse Act of 1986 was a law pertaining to the War on Drugs passed by the U.S. Congress and signed into law by U.S. President Ronald Reagan. Among other things, it changed the system of federal supervised release from a rehabilitative system into a punitive system. [citation needed]
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 ...
The Harrison Narcotics Tax Act (Ch. 1, 38 Stat. 785) was a United States federal law that regulated and taxed the production, importation, and distribution of opiates and coca products. The act was proposed by Representative Francis Burton Harrison of New York and was approved on December 17, 1914. [ 1][ 2]