A forthcoming US Food and Drug Administration guidance on accelerated approval for gene therapies will address what Center for Biologics Evaluation and Research Director Peter Marks described as three “buckets” of scenarios for the expedited pathway’s use.
US FDA Gene Therapy Accelerated Approval Guidance Will Describe ‘Buckets’ Of Use Scenarios
Forthcoming guidance is expected to describe areas of “low-hanging fruit” and those that are more challenging for use of the expedited pathway, Center for Biologics Evaluation and Research Director Peter Marks said.
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