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Kate Rawson

Baltimore

Senior Editor at Prevision Policy

Drug regulation/health policy journalist, downhill skier, cyclist, Mom to two, school choice supporter, library lover, Baltimore believer. Tweets are all me.

Featured in: Favicon previsionpolicy.com Favicon informa.com (+5) Favicon pharmamedtechbi.com Favicon friendsofcancerresearch.org Favicon citeline.com Favicon hbw.citeline.com

Articles

  • Cell/Gene Therapy Cost Recovery Options Could Include Pre-Approval Public ‘Bridge’ Funding

    3 weeks ago | insights.citeline.com | Kate Rawson

    Cell/Gene Therapy Cost Recovery Options Could Include Pre-Approval Public ‘Bridge’ Funding Expanded funding for cost recovery could dovetail with FDA Commissioner Martin Makary’s idea for a “conditional approval” pathway based on a plausible mechanism of action. More cost recovery bridge funding could enhance rare disease drug development. (Shutterstock)

  • Pink Sheet — Cell/Gene Therapy Cost Recovery Options Could Include Pre-Approval Public ‘Bridge’ Funding - Friends of Cancer Research

    3 weeks ago | friendsofcancerresearch.org | Kate Rawson

    Expanded use of cost recovery “bridge” funding from the federal government could help ensure promising rare disease treatments gain US Food and Drug Administration approval and reach the market before sponsors run out of money and are forced to terminate clinical trials. The idea was floated during a recent Friends of Cancer Research meeting about cell and gene therapy regulatory and manufacturing challenges.

  • Sponsors Like START Rare Disease Pilot, Will Prasad Maintain Its Momentum?

    1 month ago | insights.citeline.com | Kate Rawson

    Sponsors Like START Rare Disease Pilot, Will Prasad Maintain Its Momentum? Sponsors reported faster development times for products that joined the pilot program intended to speed rare disease treatments in CBER. Before resigning as CBER director, Peter Marks said he thought the Trump Administration would continue supporting rare disease drug development. (Shutterstock)

  • Device-Like System Proposed For Low-Risk Human Cell Therapies, Tissue-Based Products At US FDA

    Mar 25, 2025 | insights.citeline.com | Kate Rawson

    Device-Like System Proposed For Low-Risk Human Cell Therapies, Tissue-Based Products At US FDA A risk-based approach to human cell therapies and tissue-based products could incentivize development and prevent bad actors from taking advantage of the current FDA system. The FDA wants to revamp its current regulatory framework for human cell and tissue-based therapies. (Shutterstock)

  • Gene Therapy Follow-Up: Balance Data Needs And Patient Burden, Bluebird Bio Exec Says

    Dec 18, 2024 | insights.citeline.com | Kate Rawson

    Gene Therapy Follow-Up: Balance Data Needs And Patient Burden, Bluebird Bio Exec SaysHimal Thakur said the required long-term safety study can replicate a clinical trial, which is not the intent. The FDA often requires 15 years of postmarket follow-up for approved gene therapies. (Shutterstock)

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Kate Rawson Powell
Kate Rawson Powell @Kate_Rawson
31 Jan 24

Looking forward to moderating at @CancerResrch’s Public Meeting “The Future of Diagnostic Tests: New Data & Modern Policy” Thursday, Feb. 1st, 2024 from 10:00AM - 2:30PM ET. Click to register here: https://t.co/ocmQe3Xh6s #AIOncology #FriendsDx #HRDFriends

Kate Rawson Powell
Kate Rawson Powell @Kate_Rawson
23 Jul 22

RT @NateSilver538: Telling a stranger how often you did or didn't get COVID is approximately as interesting a conversation as telling a str…

Kate Rawson Powell
Kate Rawson Powell @Kate_Rawson
6 Apr 22

After two years waiting for @US_FDA to figure out #audioissues during #VRBAC meetings, I can now easily hum along to each piece of hold music.