Kate Rawson
Latest From Kate Rawson
Pazdur’s Big Moment: ‘Project Odyssey’ Webinar Gives Oncology Chief External Buy-In On His Ideas To Revamp ODAC
OCE Director Richard Pazdur is known for cultivating 'Pazdur moments' during advisory committees when he feels the conversation has gone off track. A recent webinar with ODAC members created a perfect opportunity to promote his agenda.
Another Chance For VALID? Negative Reaction To FDA’s LDT Proposal May Reopen Legislative Talks
All of the witnesses testifying to a House E&C Committee hearing said they preferred the flexibility and targeted enforcement of the VALID Act to FDA’s proposed rule. Will Congress finally be spurred to act?
US FDA Advisory Panels May Look Different Across Centers, Despite Efforts To Standardize Process
As FDA is readying to go back to in-person advisory committee meetings this fall, the centers have different ideas about how to use their expert panels.
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.”