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Worldwide, the most important aggregate report is the Periodic Safety Update Report (PSUR) and Development Safety Update Report (DSUR). This is a document that is submitted to drug regulatory agencies in Europe, the US and Japan (ICH countries), as well as other countries around the world.
Based on an evaluation of the potential safety concern, The FDA may take regulatory action(s) to improve product safety and protect the public health, such as updating a product's labeling information, restricting the use of the drug, communicating new safety information to the public, or, in rare cases, removing a product from the market.
VigiBase is a World Health Organization's (WHO) global Individual Case Safety Report (ICSR) database that contains ICSRs submitted by the participating member states enrolled under WHO's international drug monitoring programme. It is the single largest drug safety data repository in the world.
The aims of RADAR are to disseminate safety reports for serious adverse drug reactions (sADRs) and to identify barriers to identification and reporting of these clinical events. Investigators have developed a well-coordinated system to accurately compile case report information on sADRs and to identify milestones associated with identification ...
The reports are created by the Best Buy Drugs team and an independent academic group, Research on Adverse Drug Events and Reports (RADAR), devoted to detecting drug safety issues. [6] The project also reports on drugs prescribed off-label to highlight common off-label uses, evaluates the clinical evidence and safety information for those uses ...
Researchers participating in a clinical trial must report all adverse events to the drug regulatory authority of the respective country where the drug or device is to be registered [e.g. Food and Drug Administration (FDA) if it is US]. Serious AEs must be reported immediately; minor AEs are 'bundled' by the sponsor and submitted later.
A leaked video of UnitedHealth CEO Andrew Witty defending claim denials after Brian Thompson’s murder has sparked backlash. Critics argue the policy contributes to medical bankruptcies and lives ...
These databases enable research on health and policy issues at the national, State, and local levels, including cost and quality of health services, medical practice patterns, access to healthcare, and outcomes of treatments. AHRQ has also developed a set of software tools to be used when evaluating hospital data.