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

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)...