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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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Grading Gottlieb: A Podcast Report Card

Prevision policy experts discuss where US FDA commissioner has been most effective, room for improvement, and what would make for a second successful year.
Leadership FDA

Patient-Focused Guidance Writing: FDA Aiming For 'Sweet Spot' In Advice

US FDA’s first guidance on patient data collection methods will be ready by June, and agency wants to get the tone right from the start; agency assures stakeholders it will be “flexible” on accepting new tools.

Drug Approval Standards Clinical Trials

No Sweat – Hyperhidrosis Patients Seek Broader Approvals; Botox Access An Issue

US FDA not looking to reduce attendance at third-party patient meetings, which deliver 'bang for the buck.' Excessive sweating is first externally led PFDD meeting for a more common condition.

Drug Approval Standards Dermatology

Orphan Drug Tax Credit Defense Adds To NORD's Legislative Challenges

Republican tax reform proposal would eliminate research credit; NORD already had its hands full countering 'misinformation' about impact of orphan drugs on drug spend; critics on Capitol Hill argue sponsors are gaming the system.

Rare Diseases Legislation

Gottlieb Defends Accelerated Approval, Scorns Access Limits By Payors

US FDA's accelerated approval pathway is more reliable and has better validated biomarkers than a decade ago, commissioner says, arguing coverage limits on AA products are not in the interest of public health.

Drug Approval Standards Private Payers

Hereditary Angioedema Patients Urge Work On Dosing, Product Shortages

US FDA's final patient-focused drug development meeting shows high interest clinical trial enrollment.

Rare Diseases Clinical Trials
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