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
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
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.
Serious allergic reactions, including anaphylactic shock, have been observed during postmarketing surveillance
in individuals receiving Afluria[R].
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.