US FDA’s Overloaded Advanced Therapies Office Eyes Organizational, Communication Changes
Office of Tissues and Advanced Therapies seeks to optimize its organizational structure and adopt more group-level communications, instead of one-on-one interactions with sponsors, to keep up with the massive growth in cell and gene therapies, director Wilson Bryan says.
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Standardizing the process for providing clarifications following sponsor meetings, particularly with regard to the written response-only format, is one of several solutions being piloted by the Office of Tissues and Advanced Therapies as part of its ‘growth program,’ which aims to expedite advances in cell/gene therapies while also improving staff satisfaction.
The upcoming review of two novel gene therapies from bluebird bio marks will be the first time the US FDA’s CTGTAC has met for a genetic product review in five years. That is a surprisingly long gap – and one that probably will not be repeated.
Clinical development programs for human gene therapy products that incorporate genome editing should address the potential risks of off-target editing as well as unintended consequences of on-target effects, agency says in new draft guidance.