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Kate Rawson

Kate Rawson is a Contributing Editor at Prevision Policy. She was a Senior Editor at The RPM Report and reporter and editor at The Pink Sheet where she covered drug regulation and reimbursement issues. During her ten-year tenure at FDC Reports, she helped launch The Pink Sheet DAILY, and also served as Managing Editor of The Rose Sheet, which covers regulatory and business news of the cosmetics industry.

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Gene Therapy Rare Diseases

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Drug Approval Standards ImmunoOncology

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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.

Advisory Committees Drug Review

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?

Legislation Diagnostics

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.

Advisory Committees Drug Review

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.

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