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PCORI Methodology Committee Begins Examining How Best To Interface With EHRs

 
• By Gregory Twachtman

Committee conducts interviews with 33 stakeholders, which reveal gaps and needs, as well as potential areas where Patient-Centered Outcomes Research Institute can help bridge research with electronic sources of data.

Finding methods to extract data from electronic sources, such as electronic health records, is among the tasks currently underway by the Patient-Centered Outcomes Research Institute’s Methodology Committee.

“As you know, there is a real advantage to having usable electronic data that’s collected in the clinical arena for...

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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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Canada, Britain And Australia Push For Greater International Regulatory Alignment

 
• By Eliza Slawther

Canada’s drug regulator is using amended drug laws to increase the use of regulatory reliance pathways to improve efficiency and support international alignment, while the UK’s MHRA has held talks with Australia’s TGA on topics including the role of AI in regulatory frameworks.

Publisher’s Spotlight: Shortlist Unveiled For Citeline Japan Awards

 
• By Ian Haydock

Shortlists of potential winners in all categories of the Citeline Japan Awards 2025 have now been released. Join us at the event in Tokyo on October 21, it’s not too late to book your table!

Ex-CDC Leaders Reveal New Details Of Kennedy’s Plans For ACIP, Vaccine Schedule

 
• By Sarah Karlin-Smith

The former CDC director and recently departed chief medical officer tell senators that Kennedy plans to target the childhood vaccine schedule despite a lack of scientific data to support his agenda.