Point-Of-Care Manufacturing Successfully Treats B-Cell Cancers; How Will FDA Regulate It?
In Cleveland and Moscow, researchers found freshly-manufactured T-cells showed faster reduction of tumor burden than cryopreserved cells, but uncertainty remains about what the clearance process for the technology will be at the US FDA.
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Soon-to-be-released white papers will FRAME how FDA plans assess products manufactured with advanced technologies as part of an initiative to reduce uncertainty for sponsors.
Agency hints of a “hybrid” future of in-person inspections supplemented by alternative tools like remote interactive evaluations.
The MHRA says its proposals for a new, tailormade regulatory regime for personalized medicines manufactured at the point of care are evidence of its “intent to move away from a common perception of regulators as a progress blocker to a progress enabler.”