The US Food and Drug Administration (FDA) has finalised guidance to assist industry developing human gene therapy products for neurodegenerative diseases.
The FDA recognised the gene therapy industry request to modify its language on the use of crossover trials, provided more detail on the use of comparability studies in assessing the effect of post-approval manufacturing changes on products and eliminated limits for residual product-related impurities.
The FDA announced: 'Changes to the guidance include clarifications to the recommendations regarding use of tumorigenic cell lines, comparability studies, and crossover designs for clinical trials. In addition, editorial changes were made to improve clarity.'
Please read Regulatory Focus for more information.
The full FDA Guidance for Industry for Human Gene Therapy for Neurodegenerative Diseases can be found here.
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