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QTc Draft Guidance For Non-Antiarrhythmic Drugs: ‘Reasonable Evidence’ Of Causal Cardiac Events Should Result In Boxed Warning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