Kate Rawson
Latest From Kate Rawson
US FDA Oncology Diagnostics Pilot Is ‘Interim Step’ To Fill VALID Void, But ‘Stuck In Neutral’
Without sponsors willing to work with them and in the absence of legislation giving FDA authority over lab-developed tests, the agency has launched internal programs to both gain more oversight – and spur innovation.
Drug-Drug Interactions: Future FDA Guidance Will Focus On Specific Modalities; Patient Website To Come
US FDA took ‘broadest’ approach possible with initial guidance on drug-drug interactions; additional documents will dive into issues specific to different therapeutic areas. But PK/PD modeling and AI alternatives will have to wait.
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.