World Regulators Wrestle With Advanced Therapies
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.
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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.
It has become standard practice for manufacturing to get early attention in the cell and gene therapy development, but logistics is often not considered until closer to commercialization, which could be a strategic mistake given the speed with which new treatments are being approved.