منابع مشابه
MarketWatch Spending On Postapproval Drug Safety
Withdrawals of high-profile pharmaceuticals have focused attention on postapproval safety surveillance. There have been no systematic assessments of spending on postapproval safety. We surveyed drug manufacturers regarding safety efforts. Mean spending on postapproval safety per company in 2003 was $56 million (0.3 percent of sales). Assuming a constant safety-to-sales ratio, we estimated that ...
متن کاملDrug Safety Unscrambling Post - Approval Drug Safety Monitoring
Among the thorny issues confronting newlyconfirmed FDA Commissioner Gottlieb is the unresolved rulemaking proposal to permit generic drug manufacturers to amend safety warnings in their labels without prior FDA approval. At present, only pioneer branded manufacturers holding New Drug Applications may make such amendments to respond to newlydiscovered evidence of a reasonable association between...
متن کاملDrug Safety - Case Reports
Literature reports of suspected adverse drug reactions (ADRs) associated with medicinal products for human use are not just an integral part of signal detection activities, but are also an important source of information for professionals involved in patient management. Therefore, it is with great pleasure that Adis (Springer) announces the launch of Drug Safety Case Reports, a new peerreviewed...
متن کاملDrug Safety 2009;
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 1. Literature Search Methodology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 1.1 Data Extraction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . ....
متن کاملImproving drug safety monitoring.
Drug safety monitoring is important in children. Young age, polypharmacy, prolonged hospitaliza-tion, being critically ill and use of unlicensed and off-label drugs have been identified as risk factors which predispose a child to experience an adverse drug reaction. In our country, the HIV/AIDS epidemic, setting up of intensive care units, increasing availability of imaging studies, and the int...
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ژورنال
عنوان ژورنال: EMBO reports
سال: 2005
ISSN: 1469-221X,1469-3178
DOI: 10.1038/sj.embor.7400353