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FDA
The United States Food and Drug Administration (FDA or US FDA) 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, 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), 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 directly related to food or drugs, but involves such things as regulating lasers, cellular phones, and condoms, as well as control of disease in contexts varying from h ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Office Of Regulatory Affairs
The Office of Global Regulatory Operations and Policy (GO), also known as the Office of Regulatory Affairs (ORA), is the part of the U.S. Food and Drug Administration (FDA) enforcing the federal laws governing biologics, cosmetics, dietary supplements, drugs, food, medical devices, radiation-emitting electronic devices, tobacco products, and veterinary medicine products which may have potentially harmful side effects for the consumer. The FDA Office of Regulatory Affairs is responsible for the enforcement of federal legislation and serves in a regulatory capacity to ensure health related products are accurately and informatively represented to the public, effective, and safe. The Office of Regulatory Affairs has legislative and regulatory authority for the specified health related products: * Biologics * Cosmetics * Dietary Supplements * Drugs * Foods * Medical Devices * Radiation-Emitting Electronic Products * Tobacco Products * Veterinary Products Organization It is organized ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Dietary Supplement
A dietary supplement is a manufactured product intended to supplement one's diet by taking a pill, capsule, tablet, powder, or liquid. A supplement can provide nutrients either extracted from food sources or that are synthetic in order to increase the quantity of their consumption. The class of nutrient compounds includes vitamins, minerals, fiber, fatty acids, and amino acids. Dietary supplements can also contain substances that have not been confirmed as being essential to life, but are marketed as having a beneficial biological effect, such as plant pigments or polyphenols. Animals can also be a source of supplement ingredients, such as collagen from chickens or fish for example. These are also sold individually and in combination, and may be combined with nutrient ingredients. The European Commission has also established harmonized rules to help insure that food supplements are safe and appropriately labeled. Creating an industry estimated to have a 2020 value of $ ... [...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 c. 7000 BC in Baluchistan where Neolithic dentists used flint-tipped drills and bowstrings. Study of 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 wasn't until the Federal Food, Drug, and Cosmetic Act (F ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Center For Food Safety And Applied Nutrition
The Center for Food Safety and Applied Nutrition (CFSAN ( )) is the branch of the United States Food and Drug Administration (FDA) that regulates food, dietary supplements, cosmetics, drugs, biologics, medical devices, and radiological products. Area of regulation "Food" within the context of FDA is a very broad term with some limitations. Products that contain meat are regulated by the U.S. Department of Agriculture's Food Safety and Inspection Service, with the exception of seafood and some exotic meats. The regulation of eggs is similarly complicated by shared responsibilities between the two agencies. Many other federal and state agencies have some overlapping or conflicting requirements for regulation of food products. For example, the United States Environmental Protection Agency (EPA) regulates levels of allowable contaminants in public drinking water, where the FDA regulates bottled water. Regulation of food also includes food additives such as preservatives and arti ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Office Of Criminal Investigations
The United States Food and Drug Administration (FDA) Office of Criminal Investigations (OCI) provides the FDA with a specific office to conduct and coordinate its criminal investigations. OCI special agents employ federal law enforcement methods and techniques in the investigation of suspected criminal violations of the Federal Food, Drug, and Cosmetic Act, the Federal Anti-Tampering Act, and other related federal statutes. OCI investigations concentrate on significant violations of these laws, with a priority on conduct that may present a large danger to the public health, The OCI is a relatively small agency, employing merely 180 Agents. The FDA regulates approximately 25 cents of every dollar spent annually by Americans, the FDA is responsible for regulating products to ensure the safety of food, drugs, biological products, medical devices, cosmetics, radiation-emitting devices, and more. The law enforcement arm of the FDA, the Office of Criminal Investigations. Pursuant to i ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Food Safety
Food safety (or food hygiene) is used as a scientific method/discipline describing handling, preparation, and storage of food in ways that prevent food-borne illness. The occurrence of two or more cases of a similar illness resulting from the ingestion of a common food is known as a food-borne disease outbreak. This includes a number of routines that should be followed to avoid potential health hazards. In this way, food safety often overlaps with food defense to prevent harm to consumers. The tracks within this line of thought are safety between industry and the market and then between the market and the consumer. In considering industry to market practices, food safety considerations include the origins of food including the practices relating to food labeling, food hygiene, food additives and pesticide residues, as well as policies on biotechnology and food and guidelines for the management of governmental import and export inspection and certification systems for foods ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Robert Califf
Robert McKinnon Califf (born 1951) is an American cardiologist who currently serves as the 25th Commissioner of the Food and Drug Administration. He was first nominated to be commissioner in September 2015 by President Barack Obama and he was confirmed by the U.S. Senate in February 2016, serving until January 20, 2017. President Joe Biden renominated Califf to head the Food and Drug Administration on November 12, 2021. He was confirmed by the Senate of February 15, 2022. Prior to becoming commissioner he had served as the Deputy Commissioner of the United States Food and Drug Administration's Office of Medical Products and Tobacco since January 2015. In 2019, he became head of medical strategy at Google parent company Alphabet Inc. Early life and education Califf was born in Anderson, South Carolina. He attended high school in Columbia, South Carolina where he was a member of the 1969 AAAA South Carolina Championship basketball team. He attended Duke University, graduati ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Over-the-counter Drug
Over-the-counter (OTC) drugs are medicines sold directly to a consumer without a requirement for a prescription from a healthcare professional, as opposed to 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 rea ..., which may be supplied only to consumers possessing a valid prescription. In many countries, OTC drugs are selected by a regulatory agency to ensure that they contain ingredients that are safe and effective when used without a physician's care. OTC drugs are usually regulated according to their active pharmaceutical ingredient (API) rather than final products. By regulating APIs instead of specific drug formulations, governments allow manufacturers the freedom to formulate ingredients, or combinations of ingredients, into proprietary mixtures. The term ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Center For Drug Evaluation And Research
The Center for Drug Evaluation and Research (CDER, pronounced "see'-der") is a division of the U.S. Food and Drug Administration (FDA) that monitors most drugs as defined in the Food, Drug, and Cosmetic Act. Some biological products are also legally considered drugs, but they are covered by the Center for Biologics Evaluation and Research. The center reviews applications for brand name, generic, and over the counter pharmaceuticals, manages US current Good Manufacturing Practice (cGMP) regulations for pharmaceutical manufacturing, determines which medications require a medical prescription, monitors advertising of approved medications, and collects and analyzes safety data about pharmaceuticals that are already on the market. CDER receives considerable public scrutiny, and thus implements processes that tend toward objectivity and tend to isolate decisions from being attributed to specific individuals. The decisions on approval will often make or break a small company's stock pr ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Center For Biologics Evaluation And Research
The Center for Biologics Evaluation and Research (CBER) is one of six main centers for the Food and Drug Administration, 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 (physician), Peter Marks, M.D., PhD. CBER is responsible for assuring the safety, purity, potency, and effectiveness of biologic medical product, biologics and related products (such as vaccines, live biotherapeutics (probiotics), blood products, and Cell therapy, cell, tissue, and Gene therapy, gene therapies). 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). Scope * Blood for transfusion and as a raw material for drug products, as well as reagents used for blood typing and other related activities -and- Blood plasma, plasma derivatives, including intravenous immunoglobulin, immunoglobulins, Hy ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Center For Devices And Radiological Health
The Center for Devices and Radiological Health (CDRH) is the branch of the United States Food and Drug Administration (FDA) responsible for the premarket approval of all medical devices, as well as overseeing the manufacturing, performance and safety of these devices. The CDRH also oversees the radiation safety performance of non-medical devices which emit certain types of electromagnetic radiation, such as cellular phones and microwave ovens. The current head of the CDRH is Jeffrey Shuren, who took over in January 2010. Regulatory classes CDRH splits medical devices into three classes with different regulatory requirements: Class 1 devices include everyday items such as toothbrushes which are unlikely to cause serious consequences if they fail. Manufacturers are required to follow what are called "general controls" which closely match ISO 9000 requirements. In addition to the general controls, Class 2 devices require a premarket notification. This process, commonly known as the ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Center For Veterinary Medicine
The Center for Veterinary Medicine (CVM) is a branch of the U.S. Food and Drug Administration (FDA) that regulates the manufacture and distribution of food, food additives, and drugs that will be given to animals. These include animals from which human foods are derived, as well as food additives and drugs for pets or companion animals. CVM is responsible for regulating drugs, devices, and food additives given to, or used on, over one hundred million companion animals, plus millions of poultry, cattle, swine, and minor animal species. Minor animal species include animals other than cattle, swine, chickens, turkeys, horses, dogs, and cats. CVM monitors the safety of animal foods and medications. Much of the center's work focuses on animal medications used in food animals to ensure that significant drug residues are not present in the meat or other products from these animals. CVM does not regulate vaccines for animals; these are handled by the United States Department of Agricul ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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