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Post FDA Amendments Act of 2007: New Definition of Pharmacovigilance

BayBiotech.NET
Recent FDA Amendments Act of 2007 has emphasized needs of active adverse event surveillance methods linking multiple sources of clinical data for analysis and further mandates creation of effective tools for post market risk identification, assessment and management of adverse events.
Legislation recognizes the limitations of traditional mainstream drug safety practices in the pharmaceutical industry that depends on the collection and analysis of safety data from clinical trials and therefore emphasizes the need of data mining from multiple sources.
In past few years, emerging need of data mining has generated lot of interest among various competitors to develop tools within the limits of privacy and confidentiality limits to meet the drug safety needs.
FDA is in the process of currently exploring, testing, and developing new methods of signal detection, data mining, and analysis of patient-level electronic healthcare data hoping that these new developed methods will complement the existing passive post market surveillance system.

To find out more about FDA’s E2E Pharmacovigilance Planning visit the link: http://www.fda.gov/RegulatoryInformation/Guidances/ucm129411.htm#f1

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