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Biologics Price Competition And Innovation Act Of 2009
The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) amends the Public Health Service Act (PHS Act) to create an abbreviated approval pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed reference biological product. The BPCI Act is closely related to the Drug Price Competition and Patent Term Restoration Act of 1984 (or referred to as the "Hatch-Waxman 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. ..."), which established abbreviated pathways for the approval of drug products under the Federal Food, Drug, and Cosmetic Act (FD&C Act). References {{Reflist United States federal health legislation United States Public Health Service United States federal patent legislation United States biotechnology law ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Public Health Service Act
The Public Health Service Act is a Law of the United States, United States federal law enacted in 1944. The full act is codified in Title 42 of the United States Code (The Public Health and Welfare), Chapter 6A (United States Public Health Service, Public Health Service). This Act provided a legislative basis for the provision of public health services in the United States. Contents The Public Health Service Act clearly established the Federal government of the United States, federal government's quarantine authority for the first time. It gave the United States Public Health Service responsibility for preventing the introduction, transmission and spread of communicable diseases from foreign countries into the United States. The Public Health Service Act granted the original authority for scientists and special consultants to be appointed "without regard to the civil-service laws", known as a Title 42 appointment. During COVID-19 pandemic in the United States, COVID-19 pandemic ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Biosimilar
A biosimilar (also known as follow-on biologic or subsequent entry biologic) is a biologic medical product that is almost an identical copy of an original product that is manufactured by a different company. Biosimilars are officially approved versions of original "innovator" products and can be manufactured when the original product's patent expires. Reference to the innovator product is an integral component of the approval. Unlike with generic drugs of the more common small-molecule type, biosimilar drugs generally exhibit high molecular complexity and may be quite sensitive to changes in manufacturing processes. Despite this heterogeneity, all biopharmaceuticals, including biosimilars, must maintain consistent quality and clinical performance throughout their lifecycle. Drug-related authorities such as the European Medicines Agency (EMA) of the European Union, the United States Food and Drug Administration (FDA), and the Health Products and Food Branch of Health Canada ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Hatch-Waxman 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 that ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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] |
United States Federal Health Legislation
United may refer to: Places * United, Pennsylvania, an unincorporated community * United, West Virginia, an unincorporated community Arts and entertainment Films * ''United'' (2003 film), a Norwegian film * ''United'' (2011 film), a BBC Two film * ''The United'' (film), an unreleased Arabic-language film Literature * ''United!'' (novel), a 1973 children's novel by Michael Hardcastle Music * United (band), Japanese thrash metal band formed in 1981 Albums * ''United'' (Commodores album), 1986 * ''United'' (Dream Evil album), 2006 * ''United'' (Marvin Gaye and Tammi Terrell album), 1967 * ''United'' (Marian Gold album), 1996 * ''United'' (Phoenix album), 2000 * ''United'' (Woody Shaw album), 1981 Songs * "United" (Judas Priest song), 1980 * "United" (Prince Ital Joe and Marky Mark song), 1994 * "United" (Robbie Williams song), 2000 * "United", a song by Danish duo Nik & Jay featuring Lisa Rowe * "United (Who We Are)", a song by XO-IQ, featured in the television se ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
United States Public Health Service
The United States Public Health Service (USPHS or PHS) is a collection of agencies of the Department of Health and Human Services which manages public health, containing nine out of the department's twelve operating divisions. The assistant secretary for health oversees the PHS. The Public Health Service Commissioned Corps (PHSCC) is the federal uniformed service of the PHS, and is one of the eight uniformed services of the United States. PHS had its origins in the system of marine hospitals that originated in 1798. In 1871, these were consolidated into the Marine Hospital Service, and shortly afterwards the position of Surgeon General and the PHSCC were established. As the system's scope grew to include quarantine authority and research, it was renamed the Public Health Service in 1912. A series of reorganizations in 1966–1973 began a shift where PHS' divisions were promoted into departmental operating agencies. PHS was established as a thin layer of hierarchy above ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
United States Federal Patent Legislation
United may refer to: Places * United, Pennsylvania, an unincorporated community * United, West Virginia, an unincorporated community Arts and entertainment Films * ''United'' (2003 film), a Norwegian film * ''United'' (2011 film), a BBC Two film * ''The United'' (film), an unreleased Arabic-language film Literature * ''United!'' (novel), a 1973 children's novel by Michael Hardcastle Music * United (band), Japanese thrash metal band formed in 1981 Albums * ''United'' (Commodores album), 1986 * ''United'' (Dream Evil album), 2006 * ''United'' (Marvin Gaye and Tammi Terrell album), 1967 * ''United'' (Marian Gold album), 1996 * ''United'' (Phoenix album), 2000 * ''United'' (Woody Shaw album), 1981 Songs * "United" (Judas Priest song), 1980 * "United" (Prince Ital Joe and Marky Mark song), 1994 * "United" (Robbie Williams song), 2000 * "United", a song by Danish duo Nik & Jay featuring Lisa Rowe * "United (Who We Are)", a song by XO-IQ, featured in the television ser ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
