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

 
• 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.  

FDA Magnify glass
• 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.

Speaking at a cell and gene therapy conference, Peter Marks, director of the Center for Biologics Evaluation and Research (CBER)...

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