FDA in the context of "Cellular phones"

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⭐ Core Definition: FDA

The Food and Drug Administration (FDA) is a federal agency of the United States 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 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 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 not directly related to food or drugs but involves other factors like regulating lasers, cellular phones, and condoms. In addition, the FDA takes control of diseases in the contexts varying from household pets to human sperm donated for use in assisted reproduction.

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In this Dossier

FDA in the context of United States patent law

Under United States law, a patent is a right granted to the inventor of a (1) process, machine, article of manufacture, or composition of matter, (2) that is new, useful, and non-obvious. A patent is the right to exclude others, for a limited time (usually, 20 years) from profiting from a patented technology without the consent of the patent holder. Specifically, it is the right to exclude others from: making, using, selling, offering for sale, importing, inducing others to infringe, applying for an FDA approval, and/or offering a product specially adapted for practice of the patent.

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FDA in the context of Tubal ligation

Tubal ligation (commonly known as having one's "tubes tied") is a surgical procedure for female sterilization in which the fallopian tubes are permanently blocked, clipped or removed. This prevents the fertilization of eggs by sperm and thus the implantation of a fertilized egg. Tubal ligation is considered a permanent method of sterilization and birth control by the FDA. Bilateral tubal ligation is not considered a sterilization method by the MHRA.

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FDA in the context of Heterocyclic

A heterocyclic compound or ring structure is a cyclic compound that has atoms of at least two different elements as members of its ring(s). Heterocyclic organic chemistry is the branch of organic chemistry dealing with the synthesis, properties, and applications of organic heterocycles.

Examples of heterocyclic compounds include all of the nucleic acids, the majority of drugs, most biomass (cellulose and related materials), and many natural and synthetic dyes. More than half of known compounds are heterocycles. 59% of US FDA-approved drugs contain nitrogen heterocycles.

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FDA in the context of Rosin

Rosin (/ˈrɒzɪn/), also known as colophony or Greek pitch (Latin: pix graeca), is a resinous material obtained from pine trees and other plants, mostly conifers. The primary components of rosin are diterpenoids, i.e., C20 carboxylic acids. Rosin consists mainly of resin acids, especially abietic acid. Rosin often appears as a semi-transparent, brittle substance that ranges in color from yellow to black and melts at stove-top temperatures.

In addition to industrial applications such as in varnishes, adhesives, and sealing wax, rosin is used with string instruments on the bow hair to enhance its ability to grip and sound the strings, and it provides grip in various sports and activities. Rosin also serves as an ingredient in medicinal and pharmaceutical formulations and can cause contact dermatitis or occupational asthma in sensitive individuals. It is an FDA approved food additive.

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FDA in the context of Barkat Pharmaceutical Group

Barkat Pharmaceutical Group (Persian: گروه دارویی برکت, Gruh-e Darvii-ye Berekât) is an Iranian Pharmaceutical public company, which was founded in 2010, named Tadbir innovation pharmaceutical company. The company provides services through cooperation between science-based institutions and scientists based on medicine around the world. It supplies 14 percent of all the country's essential drugs through its 25 subsidiaries. The company produces 700 kinds of products in the pharmaceutical sector and offers it internally.

The Barkat Pharmaceutical Group has established as the first specialized drug and pharmaceutical research center in Iran, also it has been developed by constructing advanced pharmaceutical factories, called Barkat Pharmaceutical Town. The Barkat group complies with all common pharmaceutical standards such as the FDA, WHO, EMEA. "Cell therapy", production of "peptide medications", "research, development and processing of medicinal plants," the creation of the "Museum of Iranian-Islamic Medicine" as well as "Solids and Semi-Solids" projects are the main activities of the Group.

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FDA in the context of Therapeutic vaccines

A therapeutic vaccine is a vaccine which is administered after a disease or infection has already occurred. A therapeutic vaccine works by activating the immune system of a patient to fight an infection. A therapeutic vaccine differs from a prophylactic vaccine in that prophylactic vaccines are administered to individuals as a precautionary measure to avoid the infection or disease while therapeutic vaccines are administered after the individual is already affected by the disease or infection.A therapeutic vaccine fights an existing infection in the body rather than immunizing the body for protection against future diseases and infections.Therapeutic vaccines are mostly used against viral infections. Patients affected with chronic viral infections are administered with therapeutic vaccines, as their immune system is not able to produce enough efficient antibodies.

Provenge, developed by Dendreon, was the first therapeutic vaccine approved by the FDA in 2010. This therapeutic vaccine helped in treating prostate cancer where patients' own white blood cells (WBCs) were taken and treated with drug (vaccine) to train them to differentiate and fight cancer cells.

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FDA in the context of Coagulation factor VII

Coagulation factor VII (EC 3.4.21.21, formerly known as proconvertin) is a protein involved in coagulation and, in humans, is encoded by gene F7. It is an enzyme of the serine protease class. Once bound to tissue factor released from damaged tissues, it is converted to factor VIIa (or blood-coagulation factor VIIa, activated blood coagulation factor VII), which in turn activates factor IX and factor X.

Using genetic recombination a recombinant factor VIIa (eptacog alfa) (trade names include NovoSeven) has been approved by the FDA for the control of bleeding in hemophilia. It is sometimes used unlicensed in severe uncontrollable bleeding, although there have been safety concerns. A biosimilar form of recombinant activated factor VII (AryoSeven) is also available, but does not play any considerable role in the market.

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