Kate Rawson
Latest From Kate Rawson
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?’
QTc Draft Guidance For Non-Antiarrhythmic Drugs: ‘Reasonable Evidence’ Of Causal Cardiac Events Should Result In Boxed Warning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.
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.
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.
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?
‘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.