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Orphan Drug
An orphan drug is a pharmaceutical agent developed to treat medical conditions which, because they are so rare, would not be profitable to produce without government assistance. The conditions are referred to as orphan diseases. The assignment of orphan status to a disease and to drugs developed to treat it is a matter of public policy in many countries and has yielded medical breakthroughs that might not otherwise have been achieved, due to the economics of drug research and development. In the U.S. and the EU, it is easier to gain marketing approval for an orphan drug. There may be other financial incentives, such as an extended period of exclusivity, during which the producer has sole rights to market the drug. All are intended to encourage development of drugs which would otherwise lack sufficient profit motive to attract corporate research budgets and personnel. Definition According to the US Food and Drug Administration (FDA), an orphan drug is defined as one "intended for ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Medication
A medication (also called medicament, medicine, pharmaceutical drug, medicinal drug or simply drug) is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy ( pharmacotherapy) is an important part of the medical field and relies on the science of pharmacology for continual advancement and on pharmacy for appropriate management. Drugs are classified in multiple ways. One of the key divisions is by level of control, which distinguishes prescription drugs (those that a pharmacist dispenses only on the order of a physician, physician assistant, or qualified nurse) from over-the-counter drugs (those that consumers can order for themselves). Another key distinction is between traditional small molecule drugs, usually derived from chemical synthesis, and biopharmaceuticals, which include recombinant proteins, vaccines, blood products used therapeutically (such as IVIG), gene therapy, monoclonal antibodies and cell therapy (for instance, stem cell th ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Dosing
Dosing generally applies to feeding chemicals or medicines when used in small quantities. For medicines the term '' dose'' is generally used. In the case of inanimate objects the word dosing is typical. The term dose titration, referring to stepwise adjustment of doses until a desired level of effect is reached, is common in medicine. Engineering The word ''dosing'' is very commonly used by engineers in thermal power stations, in water treatment, in any industry where steam is being generated, and in building services for heating and cooling water treatment. Dosing procedures are also in vogue in textile and similar industries where chemical treatment is involved. Commercial swimming pools also require chemical dosing in order to control pH balance, chlorine level, and other such water quality criteria. Modern swimming pool plant will have bulk storage of chemicals held in separate dosing tanks, and will have automated controls and dosing pumps to top up the various chemicals a ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Office Of Rare Diseases
The Office of Rare Diseases Research is a division of the National Center for Advancing Translational Sciences (NCATS) that oversees the Rare Diseases Clinical Research Network The Rare Diseases Clinical Research Network (RDCRN) is an initiative of the Office of Rare Diseases Research (ORDR). RDCRN is funded by the ORDR, the National Center for Advancing Translational Sciences and collaborating institute centers. The RDCR ... and Genetic and Rare Diseases Information Center. History The Office of Rare Diseases Research was established in 1993 within the Office of the Director of the NIH. Its responsibilities were mandated by statute by the Rare Diseases Act of 2002. In 2011, the office became part of the newly created NCATS. ORDR is currently headed by Dr. Anne R. Pariser, who took over the position in February 2018. References {{reflist National Institutes of Health ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Public Health Service Act
The Public Health Service Act is a 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 ( Public Health Service). Contents The act clearly established the 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, section has been used for Title 42 expulsion. Amendments It has since been amended many times. Some of these amendments are: * Family Planning Services and Population Research Act of 1970 , which established Title X of the Public Health Service Act, dedicated ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Rare Diseases Act Of 2002
The Rare Disease Act of 2002 is a law passed in the United States that establishes the statutory authorization for the Office of Rare Diseases as a federal entity able to recommend a national research agenda, coordinate research, and provide educational activities for researchers. Background A rare disease or disorder is defined in the U.S. as one affecting fewer than 200,000 Americans. There are more than 6,000 known rare diseases, and it is estimated that about 25 million Americans are affected by them (as of 2002). Prior to the RDA was the Orphan Drug Act of 1983 which was designed to facilitate the development and commercialization of drugs to treat rare diseases, termed ''orphan drugs''. This act however did not provide for the creation of a centralized structure able to coordinate research or recommend agendas that would better facilitate research and education. Legislative history S. 1379 (Rare Diseases Act of 2001) was introduced in 2001 by Sen. Edward Kennedy (D-MA) bu ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Tax Incentive
A tax incentive is an aspect of a government's taxation policy designed to incentivize or encourage a particular economic activity by reducing tax payments. Tax incentives can have both positive and negative impacts on an economy. Among the positive benefits, if implemented and designed properly, tax incentives can attract investment to a country. Other benefits of tax incentives include increased employment, higher number of capital transfers, research and technology development, and also improvement to less developed areas. Though it is difficult to estimate the effects of tax incentives, they can, if done properly, raise the overall economic welfare through increasing economic growth and government tax revenue (after the expiration of the tax holiday/incentive period). However, tax incentive can cause negative effects on a government's financial condition, among other negative effects, if they are not properly designed and implemented. There are four typical costs to tax ince ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
The New York Times
''The New York Times'' (''the Times'', ''NYT'', or the Gray Lady) is a daily newspaper based in New York City with a worldwide readership reported in 2020 to comprise a declining 840,000 paid print subscribers, and a growing 6 million paid digital subscribers. It also is a producer of popular podcasts such as '' The Daily''. Founded in 1851 by Henry Jarvis Raymond and George Jones, it was initially published by Raymond, Jones & Company. The ''Times'' has won 132 Pulitzer Prizes, the most of any newspaper, and has long been regarded as a national " newspaper of record". For print it is ranked 18th in the world by circulation and 3rd in the U.S. The paper is owned by the New York Times Company, which is publicly traded. It has been governed by the Sulzberger family since 1896, through a dual-class share structure after its shares became publicly traded. A. G. Sulzberger, the paper's publisher and the company's chairman, is the fifth generation of the family to head the ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Pharmaceutical Company
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. Intention ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
FDA Consumer
''FDA Consumer'' was a magazine published from 1967 through 2007 by the U.S. Food and Drug Administration (FDA). From 1967 to 1972 it was known as ''FDA Papers'' before changing title to ''FDA Consumer'' with volume 6 no. 6 (July/August 1972). The journal's stated focus was to provide "in-depth information on how to get healthy and stay healthy". Copies were distributed to depository libraries which selected to receive it. The FDA publication was available as an annual subscription for $14.00 domestic and $19.60 international. ''FDA Consumer'' ceased publication with volume 41 no. 2 (March-April 2007), though existing articles continue to be updated. The ''FDA Consumer'' was provided online for volumes published between 1989 and 2007. The publication archive remains available through the U.S. Government Printing Office The United States Government Publishing Office (USGPO or GPO; formerly the United States Government Printing Office) is an agency of the legislative branch of ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
National Organization For Rare Disorders
The National Organization for Rare Disorders (NORD) is an American non-profit organization aiming to provide support for individuals with rare diseases by advocating and funding research, education, and networking among service providers. It was founded in 1983 by Abbey Meyers, along with individuals and rare diseases leaders of rare disease support groups, and it is a 501(c)3 tax exempt organization. History The organization grew out of an "informal coalition" of support groups and families called together in the late 1970s to advocate legislation supporting development of orphan drugs, or drugs for treating rare diseases. They succeeded in getting the United States Congress to pass the Orphan Drug Act (ODA) in early 1983. The initial coalition was led by Abbey Meyers, whose son had Tourette syndrome. Tourette syndrome was estimated by the National Institutes of Health to affect 100,000 people in the United States. Meyers' son was helped by an experimental drug that the manuf ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
United States
The United States of America (U.S.A. or USA), commonly known as the United States (U.S. or US) or America, is a country Continental United States, primarily located in North America. It consists of 50 U.S. state, states, a Washington, D.C., federal district, five major unincorporated territories, nine United States Minor Outlying Islands, Minor Outlying Islands, and 326 Indian reservations. The United States is also in Compact of Free Association, free association with three Oceania, Pacific Island Sovereign state, sovereign states: the Federated States of Micronesia, the Marshall Islands, and the Palau, Republic of Palau. It is the world's List of countries and dependencies by area, third-largest country by both land and total area. It shares land borders Canada–United States border, with Canada to its north and Mexico–United States border, with Mexico to its south and has maritime borders with the Bahamas, Cuba, Russia, and other nations. With a population of over 333 m ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Orphan Drug Act
The Orphan Drug Act of 1983 is a law passed in the United States to facilitate development of orphan drugs—drugs for rare diseases such as Huntington's disease, myoclonus, ALS Amyotrophic lateral sclerosis (ALS), also known as motor neuron disease (MND) or Lou Gehrig's disease, is a neurodegenerative disease that results in the progressive loss of motor neurons that control voluntary muscles. ALS is the most comm ..., Tourette syndrome and muscular dystrophy which affect small numbers of individuals residing in the United States. Orphan drug designation does not indicate that the therapeutic is either safe and effective or legal to manufacture and market in the United States. That process is handled through other offices in the US Food and Drug Administration. Instead, the designation means only that the sponsor qualifies for certain benefits from the federal government, such as market exclusivity and reduced taxes. In 1982 an informal coalition of supporters and famil ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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