FDA's 'Sentinental Initiative' to improve product safety

Share this article:
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.
Share this article:
You must be a registered member of MMM to post a comment.
close

Next Article in Features

Email Newsletters

MM&M Future Leaders


Register now

Early bird $1,950 before 31 October 2014

*Group discounts available on request 

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Features

Headliner: HealthSpot's teleconnected CEO

Headliner: HealthSpot's teleconnected CEO

Steve Cashman, Founder and CEO, HealthSpot

Recruitment: The New Breed

Recruitment: The New Breed

What do healthcare agencies really want when it comes to potential employees? The answer to that question is in a constant state of flux, as technologies, clients' changing demands and ...

Read the complete September 2014 Digital Edition

Read the complete September 2014 Digital Edition

Click the above link to access the complete Digital Edition of the September 2014 issue of MM&M, with all text, charts and pictures.