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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 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 United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services.The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines ...
The Pharmacy Competition and Consumer Choice Act of 2011 (H.R. 1971) is the legislation that was introduced in the 112th United States Congress on May 24, 2011, with the full title of the bill stating to "amend the Public Health Service Act to ensure transparency and proper operation of pharmacy benefit managers". [1]
The Family Smoking Prevention and Tobacco Control Act (also known as the FSPTC Act) was signed into law by President Barack Obama on June 22, 2009. This bill changed the scope of tobacco policy in the United States by giving the FDA the ability to regulate tobacco products, similar to how it has regulated food and pharmaceuticals since the passing of the Pure Food and Drug Act in 1906.
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Health Insurance Portability and Accountability Act of 1996; Other short titles: Kassebaum–Kennedy Act, Kennedy–Kassebaum Act: Long title: An Act To amend the Internal Revenue Code of 1986 to improve portability and continuity of health insurance coverage in the group and individual markets, to combat waste, fraud, and abuse in health insurance and health care delivery, to promote the use ...
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