WHO Drafting Regulatory Convergence White Paper On Cell And Gene Therapies, US FDA's Marks Says
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.
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US FDA’s Peter Marks says companies are not exchanging information about adenoviral factors, which is probably slowing down the field. He describes NIH's plans for a bespoke gene therapy consortium for vector generation and continued efforts for regulatory harmonization.
Biologics center's director encourages sponsors to invite other regulators to early FDA meetings in effort to scale up markets.
The development of advanced therapy medicinal products is dogged by a lack of regulation and guidance and differences in what should and should not be deemed an ATMP, according to speakers at last month’s pre-ICDRA gathering of world regulators.