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Sentinel Will Start Small, FDA Tells IoM; Are Expectations Too Big?

 
• By Michael McCaughan

Agency plans to launch two "mini-Sentinel" pilots, one using private data sources and one tying together Medicare, VA and DoD data. More importantly, agency is focusing on using Sentinel for signal strengthening-that is, to test signals generated via existing means, not generate new ones. That position seems to have broad support from thought leaders in epidemiology, but may not match stakeholder expectations for Sentinel

FDA plans to launch two "mini-Sentinel" pilot projects as the next steps towards building the active surveillance capability called for under the FDA Amendments Act of 2007, Sentinel Initiative Scientific Lead Judith Racoosin told a Sept. 2 Institute of Medicine meeting focused on the drug safety system post-FDAAA.

Those projects—one testing FDA's proposed model for a distributed data network model using private data sources, the other combining government-only...

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Ocaliva: Still No Clarity On Why EU Court Opposed Revocation Of Approval

 
• By Neena Brizmohun

Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Nielsen Hobbs

This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Nielsen Hobbs

We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.

Brazil Pilots Digital Drug Pack Inserts

 
• By Francesca Bruce

A new pilot aims to take Brazil closer to ‘digital transformation.’

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HTA Expert Warns Of Escalating Measures If Pharma Fails To Tame Prices

 
• By Francesca Bruce

Too many “uninformative” drug trials fail to justify the excessively high prices of many medicines, while there is too much evidentiary uncertainty in European pricing and reimbursement systems, warned Anja Schiel from Norway’s NOMA.

Kisunla Back In The Spotlight As EMA Reconsiders Alzheimer’s Drug Rejection

 
• By Eliza Slawther

It appears that the European Medicines Agency is making progress on its re-examination of Eli Lilly’s Alzheimer’s disease drug Kisunla, following an initial rejection in March based on safety concerns.

Canada Joins Global Push To Drop Costly Clinical Trials For Biosimilars

 
• By Neena Brizmohun

Health Canada’s proposal to no longer require biosimilar manufacturers to prove the safety and efficacy of their product through Phase III clinical trials marks a pivotal change in Canada’s regulatory approach.