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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 organize ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
FDA Bldg 32 - Pathway To Main Entrance (5161375442)
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 ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Food And Drug Administration (United States)
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 var ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Form FDA 483
The U.S. Food and Drug Administration (FDA) is authorized to perform inspections under the Federal Food, Drug, and Cosmetic Act, Sec. 704 (21 USC §374) "Factory Inspection". Form FDA 483, "Inspectional Observations," is a form used by the FDA to document and communicate concerns discovered during these inspections. Also referred to as "Form 483" or merely "483", . it states thereon that it ... lists observations made by the FDA representative(s) during the inspection of your facility. They are inspectional observations, and do not represent a final Agency determination regarding your complianceA recipient of a 483 should respond to the FDA, addressing each item, indicating agreement and either providing a for cor ... [...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 safety of food, drugs, medical devices, and cosmetics. 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 influenced by the death of more than 100 patients due to elixir sulfanilamide, a sulfanilamide medication where the toxic solvent diethylene glycol w ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Public Health Service Act
The Public Health Service Act is a Law of the United States, 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 (United States Public Health Service, Public Health Service). Contents The act clearly established the Federal government of the United States, 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 in the United States, COVID-19 pandemic, section has been used for Title 42 expulsion. Amendments It has since been amended many times. Some of these amendments a ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Public Health Service
In public relations and communication science, publics are groups of individual people, and the public (a.k.a. the general public) is the totality of such groupings. This is a different concept to the sociological concept of the ''Öffentlichkeit'' or public sphere. The concept of a public has also been defined in political science, psychology, marketing, and advertising. In public relations and communication science, it is one of the more ambiguous concepts in the field. Although it has definitions in the theory of the field that have been formulated from the early 20th century onwards, and suffered more recent years from being blurred, as a result of conflation of the idea of a public with the notions of audience, market segment, community, constituency, and stakeholder. Etymology and definitions The name "public" originates with the Latin '' publicus'' (also '' poplicus''), from ''populus'', to the English word 'populace', and in general denotes some mass population ("the p ... [...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] |
FDA Warning Letter
An FDA warning letter is an official message from the United States Food and Drug Administration (FDA) to a manufacturer or other organization that has violated some rule in a federally regulated activity. The FDA defines an FDA warning letter as: ... a correspondence that notifies regulated industry about violations that FDA has documented during its inspections or investigations. Typically, a Warning Letter notifies a responsible individual or firm that the Agency considers one or more products, practices, processes, or other activities to be in violation of the Federal Food, Drug, and Cosmetic Act (the Act), its implementing regulations and other federal statutes. Warning Letters should only be issued for violations of regulatory significance, i.e., those that may actually lead to an enforcement action if the documented violations are not promptly and adequately corrected. A Warning Letter is one of the Agency's principal means of achieving prompt voluntary compliance with th ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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