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Structured Product Labeling
Structured Product Labeling (SPL) is a Health Level Seven International (HL7) standard which defines the content of human prescription drug labeling in an XML format. The "drug labeling" includes all published material accompanying a drug, such as the Prescribing Information which contains a great deal of detailed information about the drug. As of Release 4 of the SPL standard, 22,000 FDA informational product inserts have been encoded according to the standard. SPL documents contain both the content of labeling (all text, tables and figures) for a product along with additional machine readable information (drug listing data elements). Drug listing data elements include information about the product (proprietary and nonproprietary names, ingredients, ingredient strengths, dosage forms, routes of administration, appearance, DEA schedule) and the packaging (package quantity and type). Background Since October 31, 2005, labeling submissions to the FDA's Center for Drug Evaluation ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Health Level Seven International
Health Level Seven International (HL7) is a non-profit ANSI-accredited standards development organization that develops standards that provide for global health data interoperability. The 2.x versions of the standards are the most commonly used in the world. Organization The HL7 community is organized in the form of a global organization (Health Level Seven International, Inc.) and country-specific affiliate organizations: *Health Level Seven International, Inc. (HL7) is headquartered in Ann Arbor, Michigan. *HL7 has members from over 50 countries, including 500+ corporate members representing healthcare providers, government stakeholders, payers, pharmaceutical companies, vendors/suppliers, and consulting firms. *HL7 affiliate organizations, not-for-profit organizations incorporated in local jurisdictions, exist in over 30 countries. The first affiliate organization was created in Germany in 1993. *Strategic goals and initiatives are presented in HL7's Strategic Plan. The org ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
USFDA
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 h ... [...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] |
Center For Drug Evaluation And Research
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] |
National Library Of Medicine
The United States National Library of Medicine (NLM), operated by the United States federal government, is the world's largest medical library. Located in Bethesda, Maryland, the NLM is an institute within the National Institutes of Health. Its collections include more than seven million books, journals, technical reports, manuscripts, microfilms, photographs, and images on medicine and related sciences, including some of the world's oldest and rarest works. The current director of the NLM is Patricia Flatley Brennan.National Library of Medicine Welcomes New Director Dr. Patricia Flatley Brennan . ''National Library of Medicine''. August 15, 2016. History The precursor o ...[...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
DailyMed
DailyMed is a website operated by the U.S. National Library of Medicine (NLM) to publish up-to-date and accurate drug labels (also called a "package insert") to health care providers and the general public. The contents of DailyMed is provided and updated daily by the U.S. Food and Drug Administration (FDA). The FDA in turn collects this information from the pharmaceutical industry. The documents published use the HL7 version 3 Structured Product Labeling (SPL) standard, which is an XML format that combines the human readable text of the product label with structured data elements that describe the composition, form, packaging, and other properties of the drug products in detail according to the HL7 Reference Information Model (RIM). , it contained information about 140,232 drug listings. It includes an RSS feed for updated drug information. History In 2006 the FDA revised the drug label and also created DailyMed to keep prescription information up to date. See also * Consum ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Health Standards
Health, according to the World Health Organization, is "a state of complete physical, Mental health, mental and social well-being and not merely the absence of disease and infirmity".World Health Organization. (2006)''Constitution of the World Health Organization''– ''Basic Documents'', Forty-fifth edition, Supplement, October 2006. A variety of definitions have been used for different purposes over time. Health can be promoted by encouraging healthful activities, such as regular physical exercise and adequate sleep, and by reducing or avoiding unhealthful activities or situations, such as smoking or excessive Stress (biology), stress. Some factors affecting health are due to Agency (sociology), individual choices, such as whether to engage in a high-risk behavior, while others are due to Social structure, structural causes, such as whether the society is arranged in a way that makes it easier or harder for people to get necessary healthcare services. Still, other factors are be ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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