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Although the advantages of a postmarketing surveillance system are self-evident, it is also important to consider the associated limitations, which include difficulties with adverse event recognition, underreporting, biases and report quality.
Performing this type of postmarketing surveillance is in fact a "grand challenge" because of the uncontrolled nature of aggregated EHR data.
They describe the use and integration of methodologies to assess the cardiac safety of noncardiac drugs during all phases of life cycle of development, from discovery and design through postmarketing surveillance.
Postmarketing surveillance data available to date do not suggest that RotaTeq is associated with intussusception.
In order to facilitate the rapid penetration of Avelox(R) Tablet into the Japanese market, both companies will continue to work closely together in the areas of marketing and postmarketing surveillance.
Postmarketing surveillance and adverse drug reactions: current perspectives and future needs.
Can Postmarketing Surveillance Provide Useful Information about the Allergenicity of Genetically Modified Foods?
cautioned that postmarketing surveillance data, evaluating rosiglitazone's effects in a much larger patient population, are required before the drug's hepatic safety profile can be fully defined.
The committee is calling for an independent body of scientists that would conduct postmarketing surveillance of adverse reactions to drugs.
The major components of the Act are increased data requirements for devices submitted under a 510k, requirement for increased postmarketing surveillance, establishment of registries for some devices, and more rigorous reporting of serious adverse events associated with the use of devices.
FDA postmarketing surveillance activities have verified that the mentioned food products have not gone through the registration process of the agency and have not been issued the proper authorization in the form of [a] certificate of product registration,' it added.