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Regulatory Affairs
Regulatory affairs (RA), is a profession that deals with an organization’s adherence to regulatory compliance. It is a position mostly found within regulated industries, such as pharmaceuticals, medical devices, cosmetics, agrochemicals (plant protection products and fertilizers), energy, banking, telecom etc. Regulatory affairs also has a very specific meaning within the healthcare industries (pharmaceuticals, medical devices, biologics and functional foods). Regulatory affairs professionals, also known as regulatory compliance professionals, usually have responsibility for the following general areas: * Ensuring that their companies comply with all of the regulations and laws pertaining to their business. * Working with federal, state, and local regulatory agencies and personnel on specific issues affecting their business, i.e., working with such agencies as the Food and Drug Administration or European Medicines Agency (pharmaceuticals and medical devices); The Departmen ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Regulatory Compliance
In general, compliance means conforming to a rule, such as a specification, policy, standard or law. Compliance has traditionally been explained by reference to deterrence theory, according to which punishing a behavior will decrease the violations both by the wrongdoer (specific deterrence) and by others (general deterrence). This view has been supported by economic theory, which has framed punishment in terms of costs and has explained compliance in terms of a cost-benefit equilibrium (Becker 1968). However, psychological research on motivation provides an alternative view: granting rewards (Deci, Koestner and Ryan, 1999) or imposing fines (Gneezy Rustichini 2000) for a certain behavior is a form of extrinsic motivation that weakens intrinsic motivation and ultimately undermines compliance. Regulatory compliance describes the goal that organizations aspire to achieve in their efforts to ensure that they are aware of and take steps to comply with relevant laws, policies, an ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
The Jungle
''The Jungle'' is a novel by American author and muckraking-journalist Upton Sinclair, known for his efforts to expose corruption in government and business in the early 20th century. In 1904, Sinclair spent seven weeks gathering information while working incognito in the meatpacking plants of the Union Stock Yards in Chicago for the socialist newspaper ''Appeal to Reason (newspaper), Appeal to Reason'', which published his novel in serial form in 1905. In 1906, the novel was published in book format by Doubleday, Page & Company, Doubleday. The book literary realism, realistically depicts working-class poverty, immigrant struggle, lack of social support or welfare, harsh living and dangerous working conditions, generating hopelessness or cynicism and cruelty among the powerless. These elements are contrasted with the deeply rooted corruption of people in power. A review by Sinclair's contemporary, writer Jack London, compared ''The Jungle'' to America's most famous novel writt ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Medical Device
A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country. As a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy also increases. Further, as associated risk increases the potential benefit to the patient must also increase. Discovery of what would be considered a medical device by modern standards dates as far back as in Baluchistan where Neolithic dentists used flint-tipped drills and bowstrings. Study of Archaeology, archeology and Roman medical literature also indicate that many types of medical devices were in widespread use during the time of ancient Rome. In the United States it was not until the Federal Food, Drug, and Cosmetic Act ( ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
European Union
The European Union (EU) is a supranational union, supranational political union, political and economic union of Member state of the European Union, member states that are Geography of the European Union, located primarily in Europe. The union has a total area of and an estimated population of over 449million as of 2024. The EU is often described as a ''sui generis'' political entity combining characteristics of both a federation and a confederation. Containing 5.5% of the world population in 2023, EU member states generated a nominal gross domestic product (GDP) of around €17.935 trillion in 2024, accounting for approximately one sixth of global economic output. Its cornerstone, the European Union Customs Union, Customs Union, paved the way to establishing European Single Market, an internal single market based on standardised European Union law, legal framework and legislation that applies in all member states in those matters, and only those matters, where the states ... [...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] |
Safe Medical Device Amendments Of 1990
Safe Medical Device Amendments of 1990 or Safe Medical Devices Act sanctioned progressive reporting and tracking rules for medical devices classified by the Medical Device Regulation Act. The Act mandates reporting requirements by medical device manufacturers regarding adverse safety events and product effectiveness of devices classified as substantially equivalent to Class III medical devices. The United States Statute established the Health and Human Services Office of International Relations and a U.S. Food and Drug Administration office for regulatory activities concerning healthcare products which are considered a combinational biological, device, or drug product. The Act of Congress transferred the electronic product radiation control provisions established by the Radiation Control for Health and Safety Act. Congressman Henry A. Waxman and Senator Edward M. Kennedy were the chairperson sponsors of the safe medical device amendments. The H.R. 3095 legislation was passed b ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Medical Device Regulation Act
The Medical Device Regulation Act or Medical Device Amendments of 1976 was introduced by the 94th Congress of the United States. Congressman Paul G. Rogers and Senator Edward M. Kennedy were the chairperson sponsors of the medical device amendments. The Title 21 amendments were signed into law on May 28, 1976, by the 38th President of the United States Gerald R. Ford. The U.S. legislation enacted in 1976 amended the Food, Drug, and Cosmetic Act of 1938 signed by the 32nd President of the United States Franklin D. Roosevelt Franklin Delano Roosevelt (January 30, 1882April 12, 1945), also known as FDR, was the 32nd president of the United States, serving from 1933 until his death in 1945. He is the longest-serving U.S. president, and the only one to have served .... History During the 1960s, the Secretary of Health, Education, and Welfare (HEW) commissioned the Cooper Committee to study the adverse effects of medical devices for human use. In 1970, the study committee ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Kefauver Harris Amendment
Carey Estes Kefauver ( ; July 26, 1903 – August 10, 1963) was an American politician from Tennessee. A member of the Democratic Party, he served in the U.S. House of Representatives from 1939 to 1949 and in the U.S. Senate from 1949 until his death in 1963. He was the winner of the 1952 Democratic Party presidential primaries, though he was not nominated at the convention. After leading a much-publicized investigation into organized crime in the early 1950s, he twice sought his party's nomination for President of the United States. In 1956, he was selected by the Democratic National Convention to be the running mate of presidential nominee Adlai Stevenson. He continued to hold his U.S. Senate seat after the Stevenson–Kefauver ticket lost to the Eisenhower–Nixon ticket. Kefauver was named chair of the U.S. Senate Antitrust and Monopoly Subcommittee of the Senate Judiciary Committee in 1957 and served as its chairman until his death. Early life Carey Estes Kefauv ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Thalidomide
Thalidomide, sold under the brand names Contergan and Thalomid among others, is an oral administered medication used to treat a number of cancers (e.g., multiple myeloma), graft-versus-host disease, and many skin disorders (e.g., complications of leprosy such as skin lesions). Updated as required. Thalidomide has been used to treat conditions associated with HIV: aphthous ulcers, HIV-associated wasting syndrome, diarrhea, and Kaposi's sarcoma, but increases in HIV viral load have been reported. Common side effects include sleepiness, rash, and dizziness. Severe side effects include tumor lysis syndrome, blood clots, and peripheral neuropathy. Thalidomide is a known human teratogen and carries an extremely high risk of severe, life-threatening birth defects if administered or taken during pregnancy. It causes skeletal deformities such as Amelia (birth defect), amelia (absence of legs and/or arms), absence of bones, and phocomelia (malformation of the limbs). A single dose of t ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Federal Food, Drug, And Cosmetic Act
The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C) is a set of laws passed by the United States Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the food safety, safety of food, drugs, medical devices, and cosmetics. The FDA's principal representative with members of congress during its drafting was Charles W. Crawford (chemist), Charles W. Crawford. A principal author of this law was Royal S. Copeland, a three-term U.S. senator from New York. In 1968, the Electronic Product Radiation Control provisions were added to the FD&C. Also in that year the FDA formed the Drug Efficacy Study Implementation (DESI) to incorporate into FD&C regulations the recommendations from a National Academy of Sciences investigation of effectiveness of previously marketed drugs. The act has been amended many times, most recently to add requirements about bioterrorism preparations. The introduction of this act was influe ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
