FDA Ban Creates Uncertainty for Overseas Trials

Clinical Trials Arena recently explored the impact of the FDA’s decision to halt cell and gene therapy trials that export US citizens’ cells to “hostile countries” for genetic engineering. The ruling raises questions for smaller biotech companies that rely on overseas facilities, potentially driving up costs and creating operational hurdles.

Anshul Mangal, CEO of Project Farma and President of PerkinElmer OneSource, was consulted for his expert perspective, discussing how the policy may accelerate investment in US-based manufacturing and reshape strategies for CGT developers.

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