Long periods of follow-up may be necessary for gene therapies, particularly if and when the US Food and Drug Administration is willing to grant a company an accelerated approval for such a treatment, FDA Commissioner Robert Califf said.
Califf: Decades Of Follow-Up Necessary For Gene Therapy
FDA Commissioner Califf acknowledges that regulatory pathways for gene therapies are still being developed and that many factors outside of the modality impact agency requirements as he emphasized the need for long-term follow up due to the unknowns of gene modification.
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