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Epedigree
An epedigree (sometimes referred to as e-pedigree or electronic pedigree) is an electronic document which provides data on the history of a particular batch of a drug. It satisfies the requirement for a drug pedigree while using a convenient electronic form. Pedigree The U.S. Food and Drug Administration (FDA) in the 2006 Compliance Policy Guide for the Prescription Drug Marketing Act states that: "A drug pedigree is a statement of origin that identifies each prior sale, purchase, or trade of a drug, including the date of those transactions and the names and addresses of all parties to them." An epedigree is simply an electronic document which satisfies the pedigree requirement. The primary purpose of an epedigree is to protect consumers from any contaminated medicine or counterfeit drugs. Standard On January 5, 2007 EPCglobal ratified the Pedigree Standard as an international standard that specifies an XML description of the life history of a product across an arbitrari ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Drug Pedigree
An epedigree (sometimes referred to as e-pedigree or electronic pedigree) is an electronic document which provides data on the history of a particular batch of a drug. It satisfies the requirement for a drug pedigree while using a convenient electronic form. Pedigree The U.S. Food and Drug Administration (FDA) in the 2006 Compliance Policy Guide for the Prescription Drug Marketing Act states that: "A drug pedigree is a statement of origin that identifies each prior sale, purchase, or trade of a drug, including the date of those transactions and the names and addresses of all parties to them." An epedigree is simply an electronic document which satisfies the pedigree requirement. The primary purpose of an epedigree is to protect consumers from any contaminated medicine or counterfeit drugs. Standard On January 5, 2007 EPCglobal ratified the Pedigree Standard as an international standard that specifies an XML description of the life history of a product across an arbitrar ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Counterfeit Drugs
A counterfeit medication or a counterfeit drug is a medication or pharmaceutical item which is produced and sold with the intent to deceptively represent its origin, authenticity, or effectiveness. A counterfeit drug may contain inappropriate quantities of active ingredients, or none, may be improperly processed within the body (''e.g.'', absorption by the body), may contain ingredients that are not on the label (which may or may not be harmful), or may be supplied with inaccurate or fake packaging and labeling. Counterfeit drugs are related to pharma fraud. Drug manufacturers and distributors are increasingly investing in countermeasures, such as traceability and authentication technologies, to try to minimise the impact of counterfeit drugs. Antibiotics with insufficient quantities of an active ingredient add to the problem of antibiotic resistance. Legitimate, correctly labeled, low-cost generic drugs are not counterfeit or fake (although they can be counterfeited much as br ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Electronic Document
An electronic document is any electronic media content (other than computer programs or system files) that is intended to be used in either an electronic form or as printed output. Originally, any computer data were considered as something internal — the final data output was always on paper. However, the development of computer networks has made it so that in most cases it is much more convenient to distribute electronic documents than printed ones. The improvements in electronic visual display technologies made it possible to view documents on screen instead of printing them (thus saving paper and the space required to store the printed copies). However, using electronic documents for final presentation instead of paper has created the problem of multiple incompatible file formats. Even plain text computer files are not free from this problem — e.g. under MS-DOS, most programs could not work correctly with UNIX-style text files (see newline), and for non-English s ... [...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 varying fro ... [...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] |
EPCglobal
The Electronic Product Code (EPC) is designed as a universal identifier (using a idiosyncratic numerical code for each different commodity) that provides a unique identity for every physical object anywhere in the world, for all time. The EPC structure is defined in the EPCglobal Tag Data Standard, which is a freely available standard. The canonical representation of an EPC is a URI, namely the 'pure-identity URI' representation that is intended for use when referring to a specific physical object in communications about EPCs among information systems and business application software. The EPCglobal Tag Data Standard also defines additional representations of an EPC identifier, such as the tag-encoding URI format and a compact binary format suitable for storing an EPC identifier efficiently within RFID tags (for which the low-cost passive RFID tags typically have limited memory capacity available for the EPC/UII memory bank). The EPCglobal Tag Data Standard defines the structure of ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Spreadsheets
A spreadsheet is a computer application for computation, organization, analysis and storage of data in tabular form. Spreadsheets were developed as computerized analogs of paper accounting worksheets. The program operates on data entered in cells of a table. Each cell may contain either numeric or text data, or the results of formulas that automatically calculate and display a value based on the contents of other cells. The term ''spreadsheet'' may also refer to one such electronic document. Spreadsheet users can adjust any stored value and observe the effects on calculated values. This makes the spreadsheet useful for "what-if" analysis since many cases can be rapidly investigated without manual recalculation. Modern spreadsheet software can have multiple interacting sheets and can display data either as text and numerals or in graphical form. Besides performing basic arithmetic and mathematical functions, modern spreadsheets provide built-in functions for common financial ac ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Electronic Product Code
The Electronic Product Code (EPC) is designed as a universal identifier (using a idiosyncratic numerical code for each different commodity) that provides a unique identity for every physical object anywhere in the world, for all time. The EPC structure is defined in the EPCglobal Tag Data Standard, which is a freely available standard. The canonical representation of an EPC is a URI, namely the 'pure-identity URI' representation that is intended for use when referring to a specific physical object in communications about EPCs among information systems and business application software. The EPCglobal Tag Data Standard also defines additional representations of an EPC identifier, such as the tag-encoding URI format and a compact binary format suitable for storing an EPC identifier efficiently within RFID tags (for which the low-cost passive RFID tags typically have limited memory capacity available for the EPC/UII memory bank). The EPCglobal Tag Data Standard defines the structure ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Drug Quality And Security Act
The Drug Quality and Security Act () is a law that amended the Federal Food, Drug, and Cosmetic Act to grant the Food and Drug Administration more authority to regulate and monitor the manufacturing of compounded drugs. The bill was written in response to the New England Compounding Center meningitis outbreak that took place in 2012, which killed 64 people. The bill was signed by President Obama on November 27, 2013. Title I of the DQSA comprises the Compounding Quality Act (CQA), which amends regulations concerning compounding drugs. Title II, the Drug Supply Chain Security Act (DSCSA), established requirements to facilitate the tracing of prescription drug products through the pharmaceutical supply distribution chain. These requirements included a ten-year timeline culminating in the building of "an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States." Background The bill was introduced by Rep. Upton in ... [...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] |
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