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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 ...
Ruan v. 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 ...
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] required ...
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 ...
The CREATES Act of 2019 is a U.S. federal law which includes measures intended to reduce prices and increase the competitiveness of generic pharmaceutical drugs. Originally standalone legislation sponsored by Patrick Leahy in the Senate and David Cicilline in the House of Representatives, those bills were incorporated into the Further ...
The drug policy in the United States is the activity of the federal government relating to the regulation of drugs. Starting in the early 1900s, the United States government began enforcing drug policies. These policies criminalized drugs such as opium, morphine, heroin, and cocaine outside of medical use. The drug policies put into place are ...
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 ...
Signed into law by President George H. W. Bush on October 29, 1992. The Prescription Drug User Fee Act ( PDUFA) was a law passed by the United States Congress in 1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process. The Act provided that the FDA was entitled to ...