FDA's 'Sentinental Initiative' to improve product safety

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The FDA says it is undertaking a new initiative to develop a system to query a broad range of databases to identify possible post-marketing adverse events. The new “Sentinel Initiative” will depend on public/private partnerships to provide access to the databases.

HHS secretary Mike Leavitt told a news briefing the system will take the FDA from its current reactive dependence on voluntary reporting of safety concerns to proactive surveillance of products in the market. Drugs director Janet Woodcock told a separate news briefing the agency has talked with potential partners but has not yet offered any an opportunity to sign up.

Creating an active surveillance system such as Sentinel was one of the recommendations made by the Institute of Medicine in a 2006 report on ways to improve the safe use of drugs. As planned, the Sentinel System will fulfill some requirements of FDAAA while also meeting additional agency needs, officials said.

Woodcock said the system will give the FDA better sources of information than the current voluntary reporting.

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