|
FDA Citizen Petition
An FDA citizen petition is a process provided by the United States Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ... (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 requested various changes to the FDA petition process, which the FDA declined. In November 2016, the FDA updated t ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
United States Food And Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, 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 drug, prescription and Over-the-counter drug, over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, Animal feed, animal foods & feed and Veterinary medicine, veterinary products. The FDA's primary focus is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C). However, 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 ... [...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) — Requireme ... [...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 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 original drug developers for regulatory delays by the Food and Drug Administration. It is generally believed that the Act accomplished both goals: encouraging development of new medications and accelerating market entry of generics. 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 t ... [...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 an American trade group representing companies in the pharmaceutical industry. Founded in 1958, PhRMA lobbies on behalf of pharmaceutical companies. PhRMA is headquartered in Washington, D.C. The organization has lobbied fiercely against allowing Medicare to negotiate drug prices for Medicare recipients, and filed lawsuits against the drug price provisions in the Inflation Reduction Act. At the state level, the organization has lobbied to prevent price limits and greater price transparency for drugs. The organization claims that higher prices incentivize research and development, even though pharmaceutical spending on marketing exceeds that spent on research, including off-label promotion that has resulted in settlements in the billions of dollars. PhRMA has given substantial dark money donations to right-wing advocacy groups such ... [...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 area, related processes within an area which together satisfies an important goal for improvements within that area * Process costing, a cost allocation procedure of managerial accounting * Process management (project management), a systematic series of activities directed towards planning, monitoring the performance an ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
