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FDA's Cleveland Clinic and Duke Connection

 
• By Cole Werble

Steven Nissen (Cleveland Clinic) and Robert Califf (Duke) are well known advisers to FDA: outside experts the agency turns to on thorny issues -- especially involving cardiovascular risks. What is less recognized is the prominence of the institutions that Nissen and Califf represent and their impact on the FDA advisory committee process. The agency currently has a dozen advisory committee members from the Cleveland Clinic and Duke.

When the Food & Drug Administration took on the thorny subjects of how and when to conduct cardiovascular outcomes research for diabetes drugs at a public advisory committee earlier this summer, the agency devoted half a day to presentations by two of the most prominent academic experts on clinical trials for cardiovascular events: Cleveland Clinic medical director Steven Nissen and Duke University vice chancellor for medical research, Robert Califf.

It wasn’t surprising for FDA to turn to Nissen and Califf for help on the tough subject of changing clinical...

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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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Semaglutide: EMA Safety Probe Confirms Rare Eye Disorder Risk

 
• By Neena Brizmohun

The EU product information for Novo Nordisk’s semaglutide medicines is to be updated to include non-arteritic anterior ischemic optic neuropathy as a side effect with a frequency of “very rare.”

Infographic: Leqembi – A Geographical Comparison

 
• By Anabel Costa-Ferreira

The Pink Sheet explores how regulatory approvals for Leqembi differ around the world, and looks at what is coming next.

EU Pharma Reform: Council Proposal A ‘Step In The Right Direction’ But ‘More Work To Be Done’

 
• By Eliza Slawther

Experts from EUCOPE explain why the Council of the EU’s position on the proposed overhaul of the general pharmaceutical legislation could offer more predictability for companies than the commission’s initial offering.