Accelerated Approval For Gene Therapies: FDA’s Wilson Bryan Offers A ‘Framework’
Bryan, who oversees reviews of gene and cell therapies in US FDA’s biologics center, cautioned against falling in love with a biomarker when it is showing no ‘clinical effect.’
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OTAT Director Bryan, who has worked at the FDA for more than 20 years, will depart by the end of March as the agency’s cell and gene therapy operations are poised for a major overhaul and a large number of new hires.
The US FDA is likely to end 2022 with noticeably fewer Accelerated Approvals granted than in recent years. But it is far too early to conclude that the agency is backing off the pathway – at least in spirit.
Two required confirmatory studies will bolster application that relied on historical controls for orphan neurodegenerative disease.