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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 the ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
United States
The United States of America (U.S.A. or USA), commonly known as the United States (U.S. or US) or America, is a country primarily located in North America. It consists of 50 states, a federal district, five major unincorporated territories, nine Minor Outlying Islands, and 326 Indian reservations. The United States is also in free association with three Pacific Island sovereign states: the Federated States of Micronesia, the Marshall Islands, and the Republic of Palau. It is the world's third-largest country by both land and total area. It shares land borders with Canada to its north and with Mexico to its south and has maritime borders with the Bahamas, Cuba, Russia, and other nations. With a population of over 333 million, it is the most populous country in the Americas and the third most populous in the world. The national capital of the United States is Washington, D.C. and its most populous city and principal financial center is New York City. Paleo-Americ ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Prescription Drug Marketing Act
{{Regulation of therapeutic goods in the United States The Prescription Drug Marketing Act (PDMA) of 1987 (P.L. 100-293, 102 Stat. 95) is a law of the United States federal government. It establishes legal safeguards for prescription drug distribution to ensure safe and effective pharmaceuticals and is designed to discourage the sale of counterfeit, adulterated, misbranded, sub potent, and expired prescription drugs. It was passed in response to the development of a wholesale sub-market (known as the "diversion market") for prescription drugs. The PDMA was modified by the Prescription Drug Amendments of 1992 (P.L. 102-353, 106 Stat. 941) on August 26, 1992. The U.S. Food and Drug Administration (FDA) issued regulations implementing the PDMA in 1990 (21 C.F.R. Part 205) and 1999 (21 C.F.R. Part 203). See also * Food and Drug Administration (FDA, USA) * Drug distribution * Inverse benefit law The inverse benefit law states that the ratio of benefits to harms among patients taki ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Tamper-evident
Tamper-evident describes a device or process that makes unauthorized access to the protected object easily detected. Seals, markings, or other techniques may be tamper indicating. Tampering Tampering involves the deliberate altering or adulteration of information, a product, a package, or system. Solutions may involve all phases of product production, distribution, logistics, sale, and use. No single solution can be considered as "tamper proof". Often multiple levels of security need to be addressed to reduce the risk of tampering. Some considerations might include: *Identify who a potential tamperer might be and what level of knowledge, materials, tools, etc. might they have. *Identify all feasible methods of unauthorized access into a product, package, or system. In addition to the primary means of entry, also consider secondary or "back door" methods. *Control or limit access to products or systems of interest. *Improve the tamper resistance by making tampering more difficult ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Adverse Drug Reaction
An adverse drug reaction (ADR) is a harmful, unintended result caused by taking medication. ADRs may occur following a single dose or prolonged administration of a drug or result from the combination of two or more drugs. The meaning of this term differs from the term "side effect" because side effects can be beneficial as well as detrimental. The study of ADRs is the concern of the field known as ''pharmacovigilance''. An adverse drug event (ADE) refers to any unexpected and inappropriate occurrence at the time a drug is used, whether or not associated with the administration of the drug. An ADR is a special type of ADE in which a causative relationship can be shown. ADRs are only one type of medication-related harm, as harm can also be caused by omitting to take indicated medications. Classification ADRs may be classified by e.g. cause and severity. Cause *Type A: Augmented pharmacologic effects - dose dependent and predictable :Type A reactions, which constitute approximate ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Supplement (publishing)
Advertising supplements periodically accompany corresponding newspapers and are prepared by the paper's advertising staff instead of its editorial staff. It is common for them to cover topics such as real estate and automobiles on behalf of the paper's frequent advertisers. Some supplements are spin-offs from a newspaper. They are sold separately and typically cover a specific topic, such as the ''Times Literary Supplement'' and the ''Times Educational Supplement'' Supplements found on some DVDs, HD DVDs, and Blu-rays are more commonly known as special features, bonus features, or bonus material. In education, supplemental materials are educational materials designed to accompany or expand on the information presented on course textbooks. These can include printed materials, CDs, websites, or other electronic materials. In academic publishing, some journals publish supplements, which often either cover an industry-funded conference or are "symposia" on a given topic. These supple ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Formulations
Formulation is a term used in various senses in various applications, both the material and the abstract or formal. Its fundamental meaning is the putting together of components in appropriate relationships or structures, according to a formula. Etymologically ''formula'' is the diminutive of the Latin ''forma'', meaning shape. In that sense a ''formulation'' is created according to the standard for the product. Abstract applications Disciplines in which one might use the word ''formulation'' in the abstract sense include logic, mathematics, linguistics, legal theory, and computer science. For details, see the related articles. Material applications In more material senses the concept of ''formulation'' appears in the physical sciences, such as physics, chemistry, and biology. It also is ubiquitous in industry, engineering and medicine, especially pharmaceutics. Pharmacy In pharmacy, a formulation is a mixture or a structure such as a capsule, tablet, or an emulsion, ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Advertising
Advertising is the practice and techniques employed to bring attention to a product or service. Advertising aims to put a product or service in the spotlight in hopes of drawing it attention from consumers. It is typically used to promote a specific good or service, but there are wide range of uses, the most common being the commercial advertisement. Commercial advertisements often seek to generate increased consumption of their products or services through "branding", which associates a product name or image with certain qualities in the minds of consumers. On the other hand, ads that intend to elicit an immediate sale are known as direct-response advertising. Non-commercial entities that advertise more than consumer products or services include political parties, interest groups, religious organizations and governmental agencies. Non-profit organizations may use free modes of persuasion, such as a public service announcement. Advertising may also help to reassure employees ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Software
Software is a set of computer programs and associated documentation and data. This is in contrast to hardware, from which the system is built and which actually performs the work. At the lowest programming level, executable code consists of machine language instructions supported by an individual processor—typically a central processing unit (CPU) or a graphics processing unit (GPU). Machine language consists of groups of binary values signifying processor instructions that change the state of the computer from its preceding state. For example, an instruction may change the value stored in a particular storage location in the computer—an effect that is not directly observable to the user. An instruction may also invoke one of many input or output operations, for example displaying some text on a computer screen; causing state changes which should be visible to the user. The processor executes the instructions in the order they are provided, unless it is instructed ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Computer Application
A computer is a machine that can be programmed to carry out sequences of arithmetic or logical operations (computation) automatically. Modern digital electronic computers can perform generic sets of operations known as programs. These programs enable computers to perform a wide range of tasks. A computer system is a nominally complete computer that includes the hardware, operating system (main software), and peripheral equipment needed and used for full operation. This term may also refer to a group of computers that are linked and function together, such as a computer network or computer cluster. A broad range of industrial and consumer products use computers as control systems. Simple special-purpose devices like microwave ovens and remote controls are included, as are factory devices like industrial robots and computer-aided design, as well as general-purpose devices like personal computers and mobile devices like smartphones. Computers power the Internet, which links bil ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Packaging And Labeling
Packaging is the science, art and technology of enclosing or protecting products for distribution, storage, sale, and use. Packaging also refers to the process of designing, evaluating, and producing packages. Packaging can be described as a coordinated system of preparing goods for transport, warehousing, logistics, sale, and end use. Packaging contains, protects, preserves, transports, informs, and sells. In many countries it is fully integrated into government, business, institutional, industrial, and personal use. Package labeling (American English) or labelling (British English) is any written, electronic, or graphic communication on the package or on a separate but associated label. History of packaging Ancient era The first packages used the natural materials available at the time: baskets of reeds, wineskins (bota bags), wooden boxes, pottery vases, ceramic amphorae, wooden barrels, woven bags, etc. Processed materials were used to form packages as they were developed ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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