FDA's CMC Guidance For Investigational Gene Therapies Reflects Broader CMC Evolution
New draft document addresses issues with applying quality-by-design to gene therapies, accommodating the Common Technical Document format, as well as drug substance, cell bank and contract manufacturing issues. US FDA's Denise Gavin offers insights on agency thinking at gene therapy conference.
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Risk-based approaches are needed to handle the flexibility, subjectivity and unpredictability that comes with quality reviews of these new technologies, Pfizer official says.