Article preview from "The Pink Sheet" January 6, 2009
FDA's ongoing challenges with effectively communicating the risks indicated by postmarket safety signals need to be resolved before the agency activates its Sentinel surveillance program, a number of participants said during a Dec. 16 FDA workshop. Read on...
Article preview from "The Pink Sheet" January 6, 2009
FDA's ongoing challenges with effectively communicating the risks indicated by postmarket safety signals need to be resolved before the agency activates its Sentinel surveillance program, a number of participants said during a Dec. 16 FDA workshop.
Participants inside and outside the agency emphasized the importance of developing and testing a risk communication strategy prior to releasing findings from Sentinel.
The workshop was sponsored by FDA and the eHealth Initiative and convened in collaboration with the Brookings Institution.
The session was intended to generate stakeholder input on some of the basic issues related to the project, which is still in the development stage.
Sentinel is envisioned as a national network of electronic databases that would be used by FDA to monitor the safety of drugs and other medical products.
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