Gene Editing: Off-Target Effects Should Be A Key Safety Focus During Development, US FDA Says
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the potential risks of off-target editing as well as unintended consequences of on-target effects, agency says in new draft guidance.
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Gene Therapy Development Should Involve Fewer Surprises, Says US FDA’s Marks
Regulators want to help smooth the process of bringing a gene therapy to market, hoping to iron out ‘surprises’ and even address reimbursement issues for the sake of patients.
Editing The Future
Gene editing is positioning itself as the latest evolution of genetic therapies and is due for an inflection point in 2022 as a number of milestones will be reached.
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.