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FDA Leader: We Need To Remove Surprises From Gene Therapy Development

Peter Marks Addresses Commercial And Regulatory Hurdles

 
• By Andrew McConaghie

Embattled gene therapy companies will take comfort from desire of FDA and EMA help smooth the process of bringing the novel treatments to market.

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: Shutterstock

Amid ongoing difficulties in the development and approval of gene therapies, US and EU regulatory leaders have said they want to help biopharma to reduce the hold-ups and surprises which have plagued the sector - though the industry may well reflect that this is a two-way street.

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