Gottlieb On Gene Therapies: 'Very Seductive' To Think About Accelerated Approval Pathway
Accelerated approval would help agency monitor gene therapies for durability and off-target effects, US FDA commissioner says.
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Outgoing commissioner say he has 'extreme confidence' in soon-to-be-acting Commissioner Ned Sharpless and other agency leaders, and expects initiatives advanced during his tenure will be ‘encapsulated and enshrined in regulation and policy’ because they are built on a solid administrative record.
Advances in cancer, diabetes, and Alzheimer's could lead to expensive new treatments, contributing to spending increases in next decade, according to CMS projections.
FDA continues to emphasize the routine and the positive, even though strains on staff and sponsors increase as shutdown grinds on. CBER's new clinical reviewers would oversee the clinical investigation, development and review of cell and gene therapies, although a timeline on the hiring is unclear.