Gene Therapy Development Should Involve Fewer Surprises, Says US FDA’s Marks

 
• By Andrew McConaghie

Regulators want to help smooth the process of bringing a gene therapy to market, hoping to iron out ‘surprises’ and even address reimbursement issues for the sake of patients.

CBER Dir. Peter Marks at Reagan-Udall Foundation for FDA.
PETER MARKS ADMITS THE FDA WAS SURPRISED BY SOME EFFICACY AND DURABILITY ISSUES IN GENE THERAPY - BUT THINKS THESE WILL BE JUST A 'BUMP IN THE ROAD'. • Source: Danny Al-Faruque

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