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Authorized Generics
Authorized generics are prescription drugs produced by brand pharmaceutical companies and marketed under a private label, at generic prices. Authorized generics compete with generic products in that they are identical to their brand counterpart in both active and inactive ingredients; whereas according to the U.S. Food and Drug Administration's Office of Generic Drugs, generic drugs are required to contain only the identical active ingredients as the brand. Authorized generics compete with generics on price, quality and availability in the generic marketplace, and are marketed to consumers during and after what is commonly known as “the 180-day exclusivity period”. In 2011 the FTC issued a final report on authorized generics (following its 2009 interim report) that showed that when innovator companies launched authorized generics during the 180 day exclusivity period granted to the first generic company to file an ANDA, prices were significantly lower that when there was no auth ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Prescription Drugs
A prescription drug (also prescription medication or prescription medicine) is a pharmaceutical drug that legally requires a medical prescription to be dispensed. In contrast, over-the-counter drugs can be obtained without a prescription. The reason for this difference in substance control is the potential scope of misuse, from drug abuse to practicing medicine without a license and without sufficient education. Different jurisdictions have different definitions of what constitutes a prescription drug. In North America, ℞, usually printed as "Rx", is used as an abbreviation of the word "prescription". It is a contraction of the Latin word "''recipe''" (an imperative form of "recipere") meaning "take". Prescription drugs are often dispensed together with a monograph (in Europe, a Patient Information Leaflet or PIL) that gives detailed information about the drug. The use of prescription drugs has been increasing since the 1960s. Regulation Australia In Australia, the Standa ... [...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), 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 d ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Generic Drugs
A generic drug is a pharmaceutical drug that contains the same chemical substance as a drug that was originally protected by chemical patents. Generic drugs are allowed for sale after the patents on the original drugs expire. Because the active chemical substance is the same, the medical profile of generics is equivalent in performance. A generic drug has the same active pharmaceutical ingredient (API) as the original, but it may differ in some characteristics such as the manufacturing process, formulation, excipients, color, taste, and packaging. Although they may not be associated with a particular company, generic drugs are usually subject to government regulations in the countries in which they are dispensed. They are labeled with the name of the manufacturer and a generic non-proprietary name such as the United States Adopted Name (USAN) or International Nonproprietary Name (INN) of the drug. A generic drug must contain the same active ingredients as the original brand-name ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Abbreviated New Drug Application
An Abbreviated New Drug Application (ANDA) is an application for a U.S. generic drug approval for an existing licensed medication or approved drug. The ANDA is submitted to Food and Drug Administration, FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, which provides for the review and ultimate approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public. Electronic submissions of ANDAs have grown by 70% since November 2008. The Section IV challenge has been credited with suppressing new drug innovation. A generic drug product is one that is comparable to a patented drug product in dosage form, strength, route of administration, quality, performance characteristics and intended use. All approved products, both innovator and generic, are listed in FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). ... [...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] |
Pharmaceutical Industry
The pharmaceutical industry discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as medications to be administered to patients (or self-administered), with the aim to cure them, vaccinate them, or alleviate symptoms. Pharmaceutical companies may deal in generic or brand medications and medical devices. They are subject to a variety of laws and regulations that govern the patenting, testing, safety, efficacy using drug testing and marketing of drugs. The global pharmaceuticals market produced treatments worth $1,228.45 billion in 2020 and showed a compound annual growth rate (CAGR) of 1.8%. History Mid-1800s – 1945: From botanicals to the first synthetic drugs The modern era of pharmaceutical industry began with local apothecaries that expanded from their traditional role of distributing botanical drugs such as morphine and quinine to wholesale manufacture in the mid-1800s, and from discoveries resulting from applied research. Intentional drug ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Pharmaceuticals Policy
Pharmaceutical policy is a branch of health policy that deals with the development, provision and use of medications within a health care system. It embraces drugs (both brand name and generic), biologics (products derived from living sources, as opposed to chemical compositions), vaccines and natural health products. Funding of research in the life sciences In many countries, an agency of the national government (in the U.S. the NIH, in the U.K. the MRC, and in India the DST) funds university researchers to study the causes of disease, which in some cases leads to the development of discoveries which can be transferred to pharmaceutical companies and biotechnology companies as a basis for drug development. By setting its budget, its research priorities and making decisions about which researchers to fund, there can be a significant impact on the rate of new drug development and on the disease areas in which new drugs are developed. For example, a major investment by the NIH into ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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