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.
When US FDA published a suite of gene therapy guidance documents on July 11 just moments before she took the podium at a cell and gene therapy conference in North Bethesda, Maryland, Denise Gavin of the agency's Center for Biologics Evaluation and Research changed her presentation to discuss the documents.
Gavin focused much of her attention on the largest and most complex of the six draft guidance documents, the...
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