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Can Social Media Help Validate Patient-Reported Outcomes? FDA Reviewer Gives “Resounding Yes”

 
• By Gregory Twachtman

Work needs to be done to allow for the use of social media to support content validity of patient-reported outcomes, but one FDA endpoints reviewer says there is a place for social media to work alongside traditional methods of validating PROs.

NEW ORLEANS – FDA’s Elektra Papadopoulos gave a clear sign that social media can be used to help validate the content of patient-reported outcomes, although she noted that a lot of work still is needed to be done before social media becomes a part of the PRO landscape.

During a May 22 panel discussion at the International Society of Pharmacoeconomics and Outcomes Research, Papadopoulos responded to the title...

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Infographic: Leqembi – A Geographical Comparison

 
• By Anabel Costa-Ferreira

The Pink Sheet explores how regulatory approvals for Leqembi differ around the world, and looks at what is coming next.

To Compete With China, US FDA Must Deregulate Early Gene Therapy Studies, CAR-T Inventor Says

 
• By Sarah Karlin-Smith

FDA regulation was painted as an obstacle to US dominance in the cell and gene therapy space even as panelists at an agency event praised the Office of Therapeutic Products' track record under Nicole Verdun.

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

 
• By Kate Rawson

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.