FDA Citizen Petition

	FDA Citizen Petition An FDA citizen petition is a process provided by the United States Food and Drug Administration (FDA) for individuals and community organizations to make requests to the FDA for changes to health policy. It is described in Title 21 of the Code of Federal Regulations (21 CFR Part 10). Pharmaceutical companies routinely use FDA citizen petitions to delay the entry of generic drugs into the United States marketplace. Companies use this to counter the parts of the Drug Price Competition and Patent Term Restoration Act, which make generic drugs more available. In 2016, Pharmaceutical Research and Manufacturers of America Pharmaceutical Research and Manufacturers of America (PhRMA, pronounced ), formerly known as the Pharmaceutical Manufacturers Association, is a trade group representing companies in the pharmaceutical industry in the United States. Founded in 195 ... requested various changes to the FDA petition process, which the FDA declined. In November 2016, the FDA updated the ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu]
picture info	United States Food And Drug Administration 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, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products. The FDA's primary focus is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C), but the agency also enforces other laws, notably Section 361 of the Public Health Service Act, as well as associated regulations. Much of this regulatory-enforcement work is not directly related to food or drugs, but involves such things as regulating lasers, cellular phones, and condoms, as well as control of disease in contexts varying from h ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu]
	Title 21 Of The Code Of Federal Regulations 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). It is divided into three chapters: * Chapter I — Food and Drug Administration * Chapter II — Drug Enforcement Administration * Chapter III — Office of National Drug Control Policy Chapter I Most of the Chapter I regulations are based on the Federal Food, Drug, and Cosmetic Act. Notable sections: * 11 — electronic records and electronic signature related * 50 Protection of human subjects in clinical trials * 54 Financial disclosure by clinical investigators * 56 Institutional review boards that oversee clinical trials * 58 Good laboratory practices (GLP) for nonclinical studies The 100 series are regulations pertaining to food: * 101, especially 101.9 — Nutrition facts label related (c)(2)(ii) — Requirement to ... [...More Info...] [...Related Items...] OR:** [Wikipedia] [Google] [Baidu]
	Drug Price Competition And Patent Term Restoration Act 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 encourages the manufacture of generic drugs by the pharmaceutical industry and established the modern system of government generic drug regulation in the United States. Representative Henry Waxman of California and Senator Orrin Hatch of Utah sponsored the act. Background Although the Federal Food, Drug, and Cosmetic Act made it possible for generic companies to get regulatory approval for drugs by filing an Abbreviated New Drug Application (ANDA), in the early 1980s it became clear that very few generics were coming to market. Congress studied the issue and realized that under patent and regulatory law, it was easy for innovator companies to make it difficult for generic companies to successfully file ANDAs and that the regulatory pathway to get ANDAs approved was irregular and uncertain. In response, the Hatch-Waxma ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu]
	Pharmaceutical Research And Manufacturers Of America Pharmaceutical Research and Manufacturers of America (PhRMA, pronounced ), formerly known as the Pharmaceutical Manufacturers Association, is a trade group representing companies in the pharmaceutical industry in the United States. Founded in 1958, PhRMA lobbies on behalf of pharmaceutical companies. PhRMA is headquartered in Washington, DC. The organization has lobbied fiercely against allowing Medicare to negotiate drug prices for Medicare recipients. At the state level, the organization has lobbied to prevent price limits and greater price transparency for drugs. PhRMA has given substantial dark money donations to right-wing advocacy groups such as the American Action Network (which lobbied heavily against the Affordable Care Act), the Koch brothers' Americans for Prosperity and Grover Norquist's Americans for Tax Reform, while rarely providing some donations to centrist or moderately right-leaning groups such as Center Forward. Membership Leadership George A. Scangos, C ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu]
	Processes From The Code Of Federal Regulations A process is a series or set of activities that interact to produce a result; it may occur once-only or be recurrent or periodic. Things called a process include: Business and management Business process, activities that produce a specific service or product for customers Business process modeling, activity of representing processes of an enterprise in order to deliver improvements Manufacturing process management, a collection of technologies and methods used to define how products are to be manufactured. Process architecture, structural design of processes, applies to fields such as computers, business processes, logistics, project management Process costing, a cost allocation procedure of managerial accounting Process management, ensemble of activities of planning and monitoring the performance of a business process or manufacturing processes Process management (project management), a systematic series of activities directed towards causing an end result in engineerin ... [...More Info...] [...Related Items...] OR:* [Wikipedia] [Google] [Baidu]