US FDA Chief Of Staff Returning To CBER For Deputy Director Role
Julie Tierney will become CBER’s deputy director for strategy, policy and legislation, a newly created position.
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Vertex’s Casgevy has made history as the world’s first approved CRISPR gene editing therapy after the UK’s MHRA authorized the medicine ahead of its US and European regulatory counterparts.
US FDA draft guidance does not specify the number of donor samples to test in nonclinical studies or the process for detecting genetic variants potentially susceptible to off-target effects. An advisory committee found adequate Vertex's analyses, which the sponsor called ‘the most comprehensive evaluation of off-target potential performed to date.’
Some worries about heritable genetic modifications are subsiding and Center for Biologics Evaluation and Research Director Peter Marks said sponsors should consider the US for regulatory advice and clinical trials in the space.