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*  Adverse drug reaction
... the Marketed Health Products Directorate of Health Canada is responsible for the surveillance of marketed health products. In ... is responsible for monitoring post-marketing studies. In Canada, ... conducts postmarket monitoring of therapeutic products. A study ...
*  Postmarketing surveillance
The FDA also conducts active surveillance of certain regulated products. For example, the FDA may monitor safety and ... "Post-marketing Surveillance". U.S. FDA/CDER. 2004. "Post-Approval Studies". U.S. FDA/CDRH. 2014. "522 Postmarket Surveillance ... Postmarketing surveillance (PMS) (also post market surveillance) is the practice of monitoring the safety of a pharmaceutical ... Postmarketing surveillance uses a number of approaches to monitor drug and device safety, including spontaneous reporting ...
*  Medicines and Healthcare products Regulatory Agency
Operate post-marketing surveillance for reporting, investigating and monitoring of adverse drug reactions to medicines and ... Medicines and Healthcare products Regulatory Agency. Retrieved 13 March 2016. "Medicines and Healthcare products Regulatory ... "the Medicines and Healthcare Products Regulatory Agency (MHRA), has failed to adequately scrutinise licensing data and its post ... Operate a quality surveillance system to sample and test medicines to address quality defects and to monitor the safety and ...
*  Adverse Event Reporting System
... post-marketing safety surveillance program for all approved drug and therapeutic biologic products. The FDA uses AERS to ... Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity ... First, there is no certainty that the reported event was actually due to the product. FDA does not require that a causal ... Based on an evaluation of the potential safety concern, FDA may take regulatory action(s) to improve product safety and protect ...
*  Center for Drug Evaluation and Research
... biotechnology products for safety and manufacturing Office of Surveillance and Epidemiology This office is responsible for post-marketing ... Some biological products are also legally considered drugs, but they are covered by the Center for Biologics Evaluation and ... The Division of Antiviral Products was added in 1989 under Drug Evaluation II due to the large amount of drugs proposed for ... and growth factors and other products designed to alter production of blood cells. U.S. FDA Center for Drug Evaluation and ...
*  Pharmaceutical industry
Postmarketing surveillance ensures that after marketing the safety of a drug is monitored closely. In certain instances, its ... The FDA review the data and if the product is seen as having a positive benefit-risk assessment, approval to market the product ... The product was formulated in diethylene glycol, a highly toxic solvent that is now widely used as antifreeze. Under the laws ... A product must pass the threshold for cost-effectiveness if it is to be approved. Treatments must represent 'value for money' ...
*  Sugar substitute
... and postmarketing surveillance, with aspartame being one of the most rigorously tested food ingredients to date. Aspartame has ... Some of the products incorporating it are Nestlé's Milo in Asia and certain Kellogg cereals in the U.S. It is also the basis of ... If the sucrose (or other sugar) that is replaced has contributed to the texture of the product, then a bulking agent is often ... Because it is so intensely sweet, relatively little of it is needed to sweeten a food product, and is thus useful for reducing ...
*  Pharmacovigilance
Indeed, the risks that are documented in a pre-authorization RMP will inevitably become part of the product's post-marketing ... SD is an essential part of drug use and safety surveillance. Ideally, the goal of SD is to identify ADRs that were previously ... Given the inherent difference between medicinal products and medical products, the vigilance of medical devices is also ... for clinical trials of medicinal products are conducted by the Swiss Agency for Therapeutic Products. In Japan, with ~12% of ...
*  Lee-Jen Wei
... monitoring and analyzing various kinds of studies in assessing postmarketing surveillance data to identify signals of safety ... science for making inferences about the drug and device safety is readily applicable to the general industry product safety ...
*  Hydroxycut
Ano Lobb (2009-04-14). "Hepatoxicity associated with weight-loss supplements: A case for better post-marketing surveillance". ... and Iovate agreed to voluntarily recall the products. The harm caused by Hydroxycut products has led to calls for stricter ... and did not disclose relationships between authors and the product manufacturer or that funding was received from the product ... The studies did not disclose that one of its authors was a chief scientific officer for GHA that holds a patent on a CQ product ...
*  Sodium oxybate
"Office of Orphan Products Development - Orphan Drug Product Designation Database". US Food and Drug Administration. 1994-11-07 ... Wang YG, Swick TJ, Carter LP, Thorpy MJ, Benowitz NL (2009). "Safety Overview of Postmarketing and Clinical Experience of ... In the letter the FDA cited 2 specific violations: 1. Failure to develop adequate written procedures for the surveillance, ... "Office of Orphan Products Development". US Food and Drug Administration. 2010-06-17. Retrieved 2010-10-03. "Fast Track, ...
*  Ofloxacin
Post-marketing surveillance has revealed a variety of relatively rare but serious adverse effects that are associated with all ... According to the product package insert, ofloxacin is effective against the following microorganisms. Aerobic Gram-positive ... Jan 7, 1991 Johnson & Johnson Going Into 1991 With At Least Four New Product Launches: Floxin, Vascor, Procrit And Duragesic; J ... One-Year Post Pediatric Exclusivity Postmarketing Adverse Events Review" (PDF). USA: FDA. Archived (PDF) from the original on ...
*  Food and Drug Administration Safety and Innovation Act
It authorizes the FDA to order post-marketing surveillance for medical devices at the time of their approval or clearance or at ... a biosimilar product application and supplement fee; (3) a biosimilar product establishment fee; and (4) a biosimilar product ... applications filed for review as fast track products, (7) applications filed for orphan-designated products, and (8) ... It expands drug product listing information to include information on drug excipient establishments, including all ...
*  Poly Implant Prothèse
British Association of Aesthetic Plastic Surgeons (BAAPS) says that poor postmarketing surveillance is the root behind the ... "Usually, from 1997 onwards we hid the products used to make the PIP gel. I wasn't allowed to buy these products because they ... The company sold a high-end product that used approved silicone for wealthier clients and which cost 5 times more than products ... They advised women that used the products to consult with a doctor and if deemed a health threat, to have them removed. The ...
*  Anthrax Vaccine Adsorbed
... have been observed during post-marketing surveillance in individuals receiving BioThrax". The approved US FDA package insert ... The product has attracted some controversy owing to alleged adverse events and questions as to whether it is effective against ... If this drug is used during pregnancy, or if the patient becomes pregnant while taking this product, the patient should be ... "Surveillance for Adverse Events Associated with Anthrax Vaccination --- U.S. Department of Defense, 1998-2000 ", MMWR, April 28 ...
*  Animal Aid
... computerised patient-drug databases and post-marketing surveillance; mathematical models and computer simulations and non- ... They also offer a quarterly magazine and a sales catalogue with cruelty-free products. Animal Aid was founded in January 1977 ...
*  Kampo
... the government conduct extensive monitoring of agricultural and manufacturing processes as well as postmarketing surveillance ... This is carried out from the blending of the raw herbs to the end product according to the Ministry's pharmaceutical standards ... Medicinal mushrooms like Reishi and Shiitake are herbal products with a long history of use. In Japan, the Agaricus blazei ... Lots of the Kampō products are routinely tested for heavy metals, purity, and microbial content to eliminate any contamination ...
*  Petasites
Postmarketing Surveillance Study". Advances in Therapy. 23 (2): 373-384. doi:10.1007/bf02850143. PMID 16751170. Taylor, ... Other sources say no butterbur product is safe: "The cases of liver toxicity appear to have occurred with extracts of butterbur ... Journal of Natural Products. 44 (2): 129-52. doi:10.1021/np50014a001. PMID 7017073. "Search results - The Plant List". ...
*  Rimonabant
When the EMA reviewed postmarketing surveillance data, it found that the risk of psychiatric disorders in people taking ... Endocrinology Products. Yoshioka, T.; et al. (1989). "Studies on hindered phenols and analogs. 1. Hypolipidemic and ... the European Medicines Agency recommended the suspension of Acomplia after the Committee for Medicinal Products for Human Use ( ...
*  Mifepristone
... but also are required to meet postmarketing surveillance to establish that the safety results shown in clinical trials are ... Exelgyn (March 25, 2015). "Mifegyne Summary of Product Characteristics (SPC)" (PDF). London: Medicines and Healthcare Products ... "Mifepristone U.S. Postmarketing Adverse Events Summary through 04/30/2011" (PDF). Archived (PDF) from the original on 2012-01- ... In 1994, Roussel Uclaf gave the U.S. drug rights to the Population Council in exchange for immunity from any product liability ...
*  Garcinia gummi-gutta
Lobb, A. (2009). "Hepatoxicity associated with weight-loss supplements: A case for better post-marketing surveillance". World ... little scientific evicence of efficacy have often led to a substantial increase in consumer purchases of the promoted products ...
*  Norfloxacin
Post-marketing surveillance has revealed a variety of relatively rare but serious adverse effects that are associated with all ... When these products are administered concomitantly, prothrombin time or other suitable coagulation tests should be closely ... One-Year Post Pediatric Exclusivity Postmarketing Adverse Events Review" (PDF). USA: FDA. Retrieved 31 August 2009. Brouwers JR ... of caffeine and a prolongation of the plasma's half-life that may lead to accumulation of caffeine in plasma when products ...
*  Lindane
The FDA, therefore, requires a so-called black box warning on lindane products, which explains the risks of lindane products ... 2006). "Surveillance of insecticide resistance in head lice using biochemical and molecular methods". Arch. Dis. Child. 91 (9 ... Lindane Post Marketing Safety Review. Posted 2003. http://www.fda.gov/cder/drug/infopage/lindane/lindaneaeredacted.pdf http:// ... It has been used to treat food crops and forestry products, as a seed treatment, a soil treatment, and to treat livestock and ...
*  Food and Drug Administration
While this remains the primary tool of postmarket safety surveillance, FDA requirements for postmarketing risk management are ... These include blood and blood products, vaccines, allergenics, cell and tissue-based products, and gene therapy products. New ... Regulation of Nonprescription Drug Products FDA. Retrieved August 30, 2012. "FDA CDER Handbook: Over-the-Counter Drug Products ... National Health Surveillance Agency Canada: Marketed Health Products Directorate Canada: Health Canada Denmark: Danish ...
*  Disease registry
... and they play an important role in post marketing surveillance of pharmaceuticals. Registries are different from indexes in ... Patient registries are particularly useful for evaluating the safety of orphan drug products as well as the safety of drugs in ... 2010). "The Value of Patient-Centered Registries in Phase IV Drug Surveillance". Pharm Med. 24 (5): 281-288. doi:10.1007/ ... 2010). "The value of patient-centred registries in phase IV drug surveillance". Pharm Med. 24 (5): 281-288. doi:10.1007/ ...
*  Weakness
... malaise in the Adverse Reactions section of the package insert to reflect reports received during post-marketing surveillance, ... Produced as a by-product of fermentation, lactic acid can increase intracellular acidity of muscles. This can lower the ... generally results in the accumulation of lactic acid and other acidic anaerobic metabolic by-products in the muscle, causing ...