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The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C) is a set of laws passed by the United States Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, medical devices, and cosmetics.
Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP). [1] It is divided into three chapters: Chapter I — Food and Drug Administration
The Drugs and Cosmetics Act, 1940 is an act of the Parliament of India which regulates the import, manufacture and distribution of drugs in India. [1] The primary objective of the act is to ensure that the drugs and cosmetics sold in India are safe, effective and conform to state quality standards. [2]
An Act to protect the public health by amending the Federal Food, Drug, and Cosmetic Act to prohibit the use in food of additives which have not been adequately tested to establish their safety. Nicknames: Delaney clause (referring to part of the amendment) Enacted by: the 85th United States Congress: Effective: September 6, 1958: Citations ...
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 drug advertising to disclose accurate information about side effects, and stopped cheap generic drugs being marketed ...
The United States Food and Drug Administration Modernization Acts (FDAMA) are amendments to the Federal Food, Drug, and Cosmetic Act, which regulated products by the FDA. The first bill, the FDA Modernization Act of 1997, reduced the timeline for approving new pharmaceutical drugs. It also loosened rules around broadcast pharmaceutical advertising.
Drug Quality and Security Act; Long title: To amend the Federal Food, Drug, and Cosmetic Act with respect to human drug compounding and drug supply chain security, and for other purposes. Announced in: the 113th United States Congress: Sponsored by: Rep. Fred Upton (R, MI-6) Number of co-sponsors: 10: Citations; Public law: Pub. L. 113–54 ...
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 ...