US FDA's Marks: Gene Therapy Success Could Hinge On Regulatory Convergence
Biologics center's director encourages sponsors to invite other regulators to early FDA meetings in effort to scale up markets.
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Regulators in high-income countries have a responsibility to help health authorities in low- and medium- income countries develop regulatory frameworks for cell and gene therapy products to ensure these treatments are available to all, asserts the US FDA’s biologics center’s director.
The EMA has declared itself satisfied with ‘refined manufacturing specifications’ for the beta thalassemia treatment
INTERACT program will allow sponsors to ask FDA questions about manufacturing and other technical issues to help streamline development.