Chart: Sentinel Initiative Starts Life With Eight Evaluation Contracts
This article was originally published in The Gray Sheet
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Sentinel governance report
FDA posts 1report May 21 by the eHealth Initiative Foundation on "Developing a Governance and Operations Structure for the Sentinel Initiative," which outlines the scope of the collaborative efforts to support FDA's Sentinel post-market safety surveillance system and recommends governance options and a phased approach to launching the effort. The report resulted from one of eight contracts awarded by the agency last year to support the Sentinel undertaking (2"The Gray Sheet" May 18, 2009, p. 14)
Sentinel Safety Surveillance Not Ideal For Every Product, Reports Find
Before considering whether to use its nascent Sentinel safety surveillance system, FDA should see whether traditional methods might work just as well, according to two reports commissioned by the agency
Abbott's ‘Bedrock Of Good Health’ Nutritionals Business Faces Mounting Infant Formula Litigation
Nutritional product business had 5.1% Q1 sales growth and is like Abbott’s other segments, “super well-aligned to the global demographics and trends in health care,” says CEO Ford. But as it defends complaints of damages from powder formulas made at facility found with unsafe levels of bacterial contaminants, Abbott’s also targeted in litigation alleging failure to warn about risk of infants born prematurely developing necrotizing enterocolitis if fed cow’s milk-based formula.