QTc Draft Guidance For Non-Antiarrhythmic Drugs: ‘Reasonable Evidence’ Of Causal Cardiac Events Should Result In Boxed Warning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.
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All drugs should undergo a single cardiac QT interval prolongation trial early in development, an International Conference on Harmonization draft guidance on clinical evaluation of QT prolongation, released Sept. 13, states
‘We’ve got these enormous markets,’ Rob Califf says. ‘Should 65% of the US population be treated with obesity drugs?’
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.