The United States Food and Drug Administration is a federal agency of the 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, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.
The Common Criteria for Information Technology Security Evaluation is an international standard for computer security certification. It is currently in version 3.1 revision 5.
Orange Book may refer to:
Health Canada is the department of the Government of Canada responsible for national health policy. The department itself is also responsible for numerous federal health-related agencies, including the Canadian Food Inspection Agency (CFIA) and the Public Health Agency of Canada (PHAC), among others. These organizations help to ensure compliance with federal law in a variety of healthcare, agricultural, and pharmaceutical activities. This responsibility also involves extensive collaboration with various other federal- and provincial-level organizations in order to ensure the safety of food, health, and pharmaceutical products—including the regulation of health research and pharmaceutical manufacturing/testing facilities.
A review is an evaluation of a publication, service, or company such as a movie, video game, musical composition, book ; a piece of hardware like a car, home appliance, or computer; or softwares such as business software, sales softwares; or an event or performance, such as a live music concert, play, musical theater show, dance show or art exhibition. In addition to a critical evaluation, the review's author may assign the work a rating to indicate its relative merit. More loosely, an author may review current events, trends, or items in the news. A compilation of reviews may itself be called a review. The New York Review of Books, for instance, is a collection of essays on literature, culture, and current affairs. National Review, founded by William F. Buckley Jr., is an influential conservative magazine, and Monthly Review is a long-running socialist periodical.
Occupational hygiene is the anticipation, recognition, evaluation, control, and confirmation of protection from hazards at work that may result in injury, illness, or affect the well being of workers. These hazards or stressors are typically divided into the categories biological, chemical, physical, ergonomic and psychosocial. The risk of a health effect from a given stressor is a function of the hazard multiplied by the exposure to the individual or group. For chemicals, the hazard can be understood by the dose response profile most often based on toxicological studies or models. Occupational hygienists work closely with toxicologists for understanding chemical hazards, physicists for physical hazards, and physicians and microbiologists for biological hazards Environmental and occupational hygienists are considered experts in exposure science and exposure risk management. Depending on an individual's type of job, a hygienist will apply their exposure science expertise for the protection of workers, consumers and/or communities.
Crystal violet or gentian violet, also known as methyl violet 10B or hexamethyl pararosaniline chloride, is a triarylmethane dye used as a histological stain and in Gram's method of classifying bacteria. Crystal violet has antibacterial, antifungal, and anthelmintic properties and was formerly important as a topical antiseptic. The medical use of the dye has been largely superseded by more modern drugs, although it is still listed by the World Health Organization.
The ISO 10993 set entails a series of standards for evaluating the biocompatibility of medical devices to manage biological risk. These documents were preceded by the Tripartite agreement and is a part of the international harmonisation of the safe use evaluation of medical devices. For the purpose of the ISO 10993 family of standards, biocompatibility is defined as the "ability of a medical device or material to perform with an appropriate host response in a specific application".
Ponceau 4R (known by more than 100 synonyms, including as C.I. 16255, Cochineal Red A, C.I. Acid Red 18, Brilliant Scarlet 3R, Brilliant Scarlet 4R, New Coccine, is a synthetic colourant that may be used as a food colouring. It is denoted by E Number E124. Its chemical name is 1- -2-napthol-6,8-disulfonic acid, trisodium salt. Ponceau is the generic name for a family of azo dyes.
A biopharmaceutical, also known as a biologic(al) medical product, or biologic, is any pharmaceutical drug product manufactured in, extracted from, or semisynthesized from biological sources. Different from totally synthesized pharmaceuticals, they include vaccines, whole blood, blood components, allergenics, somatic cells, gene therapies, tissues, recombinant therapeutic protein, and living medicines used in cell therapy. Biologics can be composed of sugars, proteins, nucleic acids, or complex combinations of these substances, or may be living cells or tissues. They are isolated from living sources—human, animal, plant, fungal, or microbial. They can be used in both human and animal medicine.
Review is an evaluation of a publication, product, service, company, or other object or idea. An article about or a compilation of reviews may itself be called a review.
The Center for Biologics Evaluation and Research (CBER) is one of six main centers for the U.S. Food and Drug Administration (FDA), which is a part of the U.S. Department of Health and Human Services. The current Director of CBER is Peter Marks, M.D., PhD. CBER is responsible for assuring the safety, purity, potency, and effectiveness of biologics and related products. Not all biologics are regulated by CBER. Monoclonal antibodies and other therapeutic proteins are regulated by the FDA Center for Drug Evaluation and Research (CDER).
A biosimilar is a biologic medical product highly similar to another already approved biological medicine. Within the European Union, biosimilars are approved according to the same standards of pharmaceutical quality, safety and efficacy that apply to all biological medicines. 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.
Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, is a publication produced by the United States Food and Drug Administration (FDA), as required by the Drug Price and Competition Act.
Blue Labour is an advocacy group associated with the British Labour Party that promotes conservative ideas on social and international issues, including immigration, crime and the European Union, rejecting neoliberal economics in favour of guild socialism and corporatism. Blue Labour advocates a switch to local and democratic community management and provision of services, rather than relying on a traditional welfare state that it sees as excessively bureaucratic. The position has been articulated in books such as Tangled Up in Blue, by Rowenna Davis, and Blue Labour, edited by Ian Geary and Adrian Pabst.
The Purple Book: A Progressive Future For Labour is a 2011 collection of essays by politicians in the UK's Labour Party, many of whom are considered to belong to the Blairite wing of the party. The book was conceived and promoted by Progress. It has been compared to The Orange Book: Reclaiming Liberalism, published seven years earlier by then-leading members of the UK's Liberal Democrats.
Pre-distribution is the idea that the state should try to prevent inequalities occurring in the first place rather than ameliorating them via tax and benefits once they have occurred, as occurs under redistribution.
Animal (De)liberation: Should the Consumption of Animal Products Be Banned? is a 2016 book, written by Jan Deckers and published by Ubiquity Press. The book engages with the work of many scholars who have written on the subject, including Carol Adams, Alasdair Cochrane, Gary Francione, Melanie Joy, Martha Nussbaum, and Peter Singer, as well as with the views of non-specialists, including slaughterhouse workers involved with the film Slaughterhouse: The Task of Blood, released by Century Films in 2005.
Minhai COVID-19 vaccine is a COVID-19 vaccine developed by Minhai Biotechnology Co. and Kangtai Biological Products Co. Ltd.
