1. Pink Sheet

US FDA’s Sentinel System Strives To Stay Ahead Of Its Own Success

 
• By Bridget Silverman

The sprawling safety surveillance system is propelling advances in informatics and advanced analytics, but the agency is delaying next contracting cycle to digest its experience.

tidal wave of data
• Source: Shutterstock

The growing sophistication of the FDA’s Sentinel safety surveillance system has multiplied the opportunities – and the challenges – surrounding the interconnected network of data partners and cutting-edge analytical tools, agency officials indicated at the FDA’s 15th Annual Sentinel Initiative Public Workshop.

“In the last 15 years, there have been so many advances in informatics and pharmacoepidemiology that enable us to better assess the quality of this digital data that we’re getting,” FDA principal deputy commissioner Janet Woodcock emphasized during the 8 November meeting

More from Drug Safety

More from Pink Sheet

Inclusive By Design: UK Pilots Diversity Plans For Drug & Device Trials

 
• By Vibha Sharma

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.

UK’s International Recognition Procedure: EU Dossier Faster Than US Or Canada

 
• By Eliza Slawther

Companies that use the European Medicines Agency as a reference regulator for the UK’s International Recognition Procedure can expect a faster approval than those that use other national regulators, such as those in the US and Canada, an MHRA spokesperson has said.

FDA Use Of Artificial Intelligence Will Help US Retain Biotech Leadership

 
• By Sue Sutter and Derrick Gingery

At a House subcommittee hearing, HHS Secretary Robert F. Kennedy Jr. rebutted lawmaker concerns that NIH cuts will drive research and scientists to other countries and said he does not want to advise parents on vaccinating children for measles, chickenpox or polio.