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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 correc ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Food And Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, 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 drug, prescription and Over-the-counter drug, over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, Animal feed, animal foods & feed and Veterinary medicine, 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 d ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Supply Chain
In commerce, a supply chain is a network of facilities that procure raw materials, transform them into intermediate goods and then final products to customers through a distribution system. It refers to the network of organizations, people, activities, information, and resources involved in delivering a product or service to a consumer. Supply chain activities involve the transformation of natural resources, raw materials, and components into a finished product and delivering the same to the end customer. In sophisticated supply chain systems, used products may re-enter the supply chain at any point where residual value is recyclable. Supply chains link value chains. Suppliers in a supply chain are often ranked by "tier", with first-tier suppliers supplying directly to the client, second-tier suppliers supplying to the first tier, and so on. Overview A typical supply chain begins with the ecological, biological, and political regulation of natural resources, followed by the ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
CDER
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] |
Fiscal Year
A fiscal year (or financial year, or sometimes budget year) is used in government accounting, which varies between countries, and for budget purposes. It is also used for financial reporting by businesses and other organizations. Laws in many jurisdictions require company financial reports to be prepared and published on an annual basis but generally not the reporting period to align with the calendar year (1 January to 31 December). Taxation laws generally require accounting records to be maintained and taxes calculated on an annual basis, which usually corresponds to the fiscal year used for government purposes. The calculation of tax on an annual basis is especially relevant for direct taxes, such as income tax. Many annual government fees—such as council tax and license fees, are also levied on a fiscal year basis, but others are charged on an anniversary basis. Some companies, such as Cisco Systems, end their fiscal year on the same day of the week each year: the day ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Sanitization (classified Information)
Sanitization is the process of removing sensitive information from a document or other message (or sometimes encrypting it), so that the document may be distributed to a broader audience. When the intent is secrecy protection, such as in dealing with classified information, sanitization attempts to reduce the document's classification level, possibly yielding an unclassified document. When the intent is privacy protection, it is often called data anonymization. Originally, the term sanitization was applied to printed documents; it has since been extended to apply to computer files and the problem of data remanence. Redaction in its sanitization sense (as distinguished from its other editing sense) is the blacking out or deletion of text in a document or the result of doing so. It is intended to allow the selective disclosure of information in a document while keeping other parts of the document secret. Typically the result is a document that is suitable for publication or for diss ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Freedom Of Information Act (United States)
The Freedom of Information Act (FOIA), , is the U.S. federal freedom of information law that requires the full or partial disclosure of previously unreleased or uncirculated information and documents controlled by the United States government, state, or other public authority upon request. The act defines agency records subject to disclosure, outlines mandatory disclosure procedures, and includes nine exemptions that define categories of information not subject to disclosure. The act was intended to make U.S. government agencies' functions more transparent so that the American public could more easily identify problems in government functioning and put pressure on Congress, agency officials, and the president to address them. The FOIA has been changed repeatedly by both the legislative and executive branches. Apart from the U.S. federal government's Freedom of Information Act, the U.S. states have their own varying freedom of information laws. The Freedom of Information Act is c ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Regulatory
Regulation is the management of complex systems according to a set of rules and trends. In systems theory, these types of rules exist in various fields of biology and society, but the term has slightly different meanings according to context. For example: * in biology, gene regulation and metabolic regulation allow living organisms to adapt to their environment and maintain homeostasis; * in government, typically regulation means stipulations of the delegated legislation which is drafted by subject-matter experts to enforce primary legislation; * in business, industry self-regulation occurs through self-regulatory organizations and trade associations which allow industries to set and enforce rules with less government involvement; and, * in psychology, self-regulation theory is the study of how individuals regulate their thoughts and behaviors to reach goals. Social Regulation in the social, political, psychological, and economic domains can take many forms: legal restriction ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Bias
Bias is a disproportionate weight ''in favor of'' or ''against'' an idea or thing, usually in a way that is closed-minded, prejudicial, or unfair. Biases can be innate or learned. People may develop biases for or against an individual, a group, or a belief. In science and engineering, a bias is a systematic error. Statistical bias results from an unfair sampling of a population, or from an estimation process that does not give accurate results on average. Etymology The word appears to derive from Old Provençal into Old French ''biais'', "sideways, askance, against the grain". Whence comes French ''biais'', "a slant, a slope, an oblique". It seems to have entered English via the game of bowls, where it referred to balls made with a greater weight on one side. Which expanded to the figurative use, "a one-sided tendency of the mind", and, at first especially in law, "undue propensity or prejudice". Types of bias Cognitive biases A cognitive bias is a repeating or basic mi ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Header (computing)
In information technology, header refers to supplemental data placed at the beginning of a block of data being stored or transmitted. In data transmission, the data following the header is sometimes called the ''payload'' or '' body''. It is vital that header composition follows a clear and unambiguous specification or format, to allow for parsing. Examples * E-mail header: The text (body) is preceded by header lines indicating sender, recipient, subject, sending time stamp, receiving time stamps of all intermediate and the final mail transfer agents, and much more. * Similar headers are used in Usenet (NNTP) messages, and HTTP headers. * In a data packet sent via the Internet, the data (payload) are preceded by header information such as the sender's and the recipient's IP addresses, the protocol governing the format of the payload and several other formats. The header's format is specified in the Internet Protocol. * In data packets sent by wireless communication, and in sectors ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
21 CFR
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) — Requirement to ... [...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 was us ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Tissue (biology)
In biology, tissue is a biological organizational level between cells and a complete organ. A tissue is an ensemble of similar cells and their extracellular matrix from the same origin that together carry out a specific function. Organs are then formed by the functional grouping together of multiple tissues. The English word "tissue" derives from the French word "tissu", the past participle of the verb tisser, "to weave". The study of tissues is known as histology or, in connection with disease, as histopathology. Xavier Bichat is considered as the "Father of Histology". Plant histology is studied in both plant anatomy and physiology. The classical tools for studying tissues are the paraffin block in which tissue is embedded and then sectioned, the histological stain, and the optical microscope. Developments in electron microscopy, immunofluorescence, and the use of frozen tissue-sections have enhanced the detail that can be observed in tissues. With these tools, the c ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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