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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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EU Health Chief Declares There Is No Better Alternative Than TEVs to Spark Antibiotic Innovation

 
• By Francesca Bruce

Clarity on what transferable exclusivity vouchers may look like for new antimicrobial drugs could be nearing. Denmark’s new presidency of the Council of the EU has prioritized concluding its negotiations with European Parliament over the legislative overhaul of the EU’s pharmaceutical legislation.

EU Fines Alchem Over Buscopan API Cartel

 
• By Dave Wallace

After pursuing Alchem International for breaches of EU antitrust rules – relating to a cartel over the SNBB pharmaceutical ingredient used in Buscopan and its generics – the European Commission has now hit the firm with a €489,000 fine.

Bayesian Statistics In EU Clinical Trials: EMA Discusses Balancing Efficiency With Rigor

 
• By Eliza Slawther

Bayesian statistics could help clinical trial sponsors to include external information in their analyses, but concerns around bias and incorrect conclusions remain, the European Medicines Agency said.