Kate Rawson
Latest From Kate Rawson
US FDA Regulatory Affairs Reorg To Include Inspectors Trained In Real-World Evidence, Califf Says
The US FDA Commissioner acknowledged that the inspectorate has not been prepared for RWE, but as part of the revamp, a dedicated team will encourage its use “when it’s appropriate.”
US FDA Regulatory Affairs Reorg To Include Inspectors Trained In Real-World Evidence, Califf Says
The US FDA Commissioner acknowledged that the inspectorate has not been prepared for RWE, but as part of the revamp, a dedicated team will encourage its use “when it’s appropriate.”
US FDA Regulatory Affairs Reorg To Include Inspectors Trained In Real-World Evidence – Califf
The US FDA Commissioner acknowledged that the inspectorate has not been prepared for RWE, but as part of the revamp, a dedicated team will encourage its use “when it’s appropriate.”
Cell/Gene Therapy Is Ripe For Real-World Data Given Length Of Follow-Up Required, Abernethy Says
The former principal deputy commissioner outlined what she sees as the future data requirements for real world evidence and why cell and gene therapy will lead the way.
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QTc Draft Guidance For Non-Antiarrhythmic Drugs: ‘Reasonable Evidence’ Of Causal Cardiac Events Should Result In Boxed Warning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.