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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 (USA), also known as the United States (U.S.) or America, is a country primarily located in North America. It is a federal republic of 50 U.S. state, states and a federal capital district, Washington, D.C. The 48 contiguous states border Canada to the north and Mexico to the south, with the semi-exclave of Alaska in the northwest and the archipelago of Hawaii in the Pacific Ocean. The United States asserts sovereignty over five Territories of the United States, major island territories and United States Minor Outlying Islands, various uninhabited islands in Oceania and the Caribbean. It is a megadiverse country, with the world's List of countries and dependencies by area, third-largest land area and List of countries and dependencies by population, third-largest population, exceeding 340 million. Its three Metropolitan statistical areas by population, largest metropolitan areas are New York metropolitan area, New York, Greater Los Angeles, Los Angel ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
New Drug Application
The Food and Drug Administration's (FDA) New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing. Some 30% or less of initial drug candidates proceed through the entire multi-year process of drug development, concluding with an approved NDA, if successful. The goals of the NDA are to provide enough information to permit FDA reviewers to establish the complete history of the candidate drug. Among facts needed for the application are: * Patent and manufacturing information * Drug safety and specific effectiveness for its proposed use(s) when used as directed * Reports on the design, compliance, and conclusions of completed clinical trials by the Institutional Review Board * Drug susceptibility to substance abuse, abuse * Proposed labeling (package insert) and directions for use Exceptions to this process include voter driven initiatives for Medical cannabis, medic ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Investigational Drug
The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved. Regulations are primarily at . Similar procedures are followed in the European Union, Japan, and Canada due to regulatory harmonization efforts by the International Council for Harmonisation. Types * Research or investigator INDs are non-commercial INDs filed by researchers to study an unapproved drug or to study an approved drug for a new indication or in a new patient population. * Emergency Use INDs, also called compassionate use or single-patient INDs, are filed for emergency use of an unapproved drug when the clinical situation does not allow sufficient time to submit an IND in accordance wit21 CFR ยงยง 312.23 312.24. These are most commonly ... [...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 * Regulation of therapeutic goods The regulation of therapeutic goods, defined as ... [...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 tamperproofing, tamper resistance by making tampering ... [...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 may 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 event (AE) refers to any unexpected and inappropriate occurrence at the time a drug is used, whether or not the event is associated with the administration of the drug. An ADR is a special type of AE in which a causative relationship can be shown. ADRs are only one type of medication-related harm. Another type of medication-related harm type includes not taking prescribed medications, known as non-adherence. Non-adherence to medications can lead to death and other negative outcomes. Adverse drug reactions require the use of a medication. Classific ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Supplement (publishing)
Supplements in the publishing industry are separately bound publications and may encompass frank advertising in newspapers, concealed advertising in academic journals supplemental educational materials in textbooks or extra volumes in reference works. In newspapers 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'' In academic journals In academic publishing, some journals publish supplements, which often either cover an industry-funded conference or are "symposia" on a given topic. These supplements are often subsidized by an external sponsor. Such supplements can ... [...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 object, abstract or wikt:formal, 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 Technical standard, standard for the product. Abstract applications Disciplines in which one might use the word ''formulation'' in the abstract sense include Formula (mathematical logic), logic, mathematics, linguistics, Law, 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 Science, physical sciences, such as physics, chemistry, and biology. It also is ubiquitous in Industrial technology, industry, engineering and medicine, especially Pharm ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Advertising
Advertising is the practice and techniques employed to bring attention to a Product (business), product or Service (economics), service. Advertising aims to present a product or service in terms of utility, advantages, and qualities of interest to Consumer, consumers. It is typically used to promote a specific good or service, but there are a wide range of uses, the most common being commercial advertisement. Commercial advertisements often seek to generate increased Consumption (economics), consumption of their products or services through "Branding (promotional), 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 marketing, direct-response advertising. Non-commercial entities that advertise more than consumer products or services include Political party, political parties, Interest group, interest groups, Religious organization, religious o ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Software
Software consists of computer programs that instruct the Execution (computing), execution of a computer. Software also includes design documents and specifications. The history of software is closely tied to the development of digital computers in the mid-20th century. Early programs were written in the machine language specific to the hardware. The introduction of high-level programming languages in 1958 allowed for more human-readable instructions, making software development easier and more portable across different computer architectures. Software in a programming language is run through a compiler or Interpreter (computing), interpreter to execution (computing), execute on the architecture's hardware. Over time, software has become complex, owing to developments in Computer network, networking, operating systems, and databases. Software can generally be categorized into two main types: # operating systems, which manage hardware resources and provide services for applicat ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Computer Application
Application software is any computer program that is intended for end-user use not operating, administering or programming the computer. An application (app, application program, software application) is any program that can be categorized as application software. Common types of applications include word processor, media player and accounting software. The term ''application software'' refers to all applications collectively and can be used to differentiate from system and utility software. Applications may be bundled with the computer and its system software or published separately. Applications may be proprietary or open-source. The short term ''app'' (coined in 1981 or earlier) became popular with the 2008 introduction of the iOS App Store, to refer to applications for mobile devices such as smartphones and tablets. Later, with introduction of the Mac App Store (in 2010) and Windows Store (in 2011), the term was extended in popular use to include desktop applic ... [...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 for 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. Many countries or regions have regulations governing the content of package labels. Merchandising, branding, and persuasive graphics are not covered in this article. History of packaging Ancient era The first packages used the natural materials available at the time: baskets ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
