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Kate Rawson

Kate Rawson is a Contributing Editor at Prevision Policy. She was a Senior Editor at The RPM Report and reporter and editor at The Pink Sheet where she covered drug regulation and reimbursement issues. During her ten-year tenure at FDC Reports, she helped launch The Pink Sheet DAILY, and also served as Managing Editor of The Rose Sheet, which covers regulatory and business news of the cosmetics industry.

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US FDA Commissioner Pushes Real-World Evidence To Guide Use Of Alzheimer’s, Obesity Drugs

‘We’ve got these enormous markets,’ Rob Califf says. ‘Should 65% of the US population be treated with obesity drugs?’

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QTc Draft Guidance For Non-Antiarrhythmic Drugs: ‘Reasonable Evidence’ Of Causal Cardiac Events Should Result In Boxed Warning

US FDA’s labeling guidance also outlines a number of steps sponsors should take to prevent or mitigate risks associated with QTc interval prolongation.

Drug Safety Drug Approval Standards

Cell Therapy Manufacturing Hurdles Could Be Solved Through AI; ‘Great Advancements’ In Next 10 Years

Artificial intelligence could be the solution to some of the process challenges with cell therapies; CBER Director Marks also suggests AI to identify safety issues with a particular vector.

Artificial Intelligence Drug Approval Standards

How Can FDA Advance Cell Therapy R&D? Issue Guidance in ‘Real Time,’ Encourage Collaboration With Industry, CBER’s Marks Says

CBER will take a page out of the drug center’s book and start issuing shorter guidances more quickly; sponsors should also be on the lookout for an RIF on ways to collaborate with agency.

Artificial Intelligence Drug Approval Standards

Are US FDA Advisory Committees Too Big? Lecanemab Shows Benefit Of Thinking Small

The advisory committee convened to consider a traditional approval for Eisai/Biogen’s Alzheimer’s antibody Leqembi was the smallest in recent memory, with just six voting members. Yet, it worked surprisingly well. Is it time to rethink the size of FDA’s expert panels?

Advisory Committees Drug Review

‘Anti-Aging’ R&D? One Drug To Prevent Many Diseases Is Possible, But Endpoints First Need Outside Work, FDA’s Califf Says

So-called ‘healthspan’ products would reduce the risk of multiple diseases; Califf seems open to the idea but said industry and outside groups must first find consensus on the science.

Drug Approval Standards Research & Development
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