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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.
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 ...
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
Drug Quality and Security Act. Compounding Quality Act Drug Supply Chain Security Act To amend the Federal Food, Drug, and Cosmetic Act with respect to human drug compounding and drug supply chain security, and for other purposes Pub. L. 113–54 (text) 113-55: November 27, 2013
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 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 ...
“Under the Federal Food, Drug, and Cosmetic Act, companies are responsible for ensuring that any use of caffeine in their products is safe. Under the Act, any substance that is intentionally ...
It amends the Federal Food, Drug, and Cosmetic Act to revise provisions regarding market exclusivity for pediatric drug studies on new or already approved drugs, including to change the definition of "pediatric studies" to authorize the Secretary to include preclinical studies, to require the studies to be completed using appropriate ...