1. Pink Sheet

Cell/Gene Therapies: Regulatory Strengthening Needed To Ensure Global Confidence

 
• By Sue Sutter

Bolstering regulatory expertise in low- and middle-income countries could help prevent a safety-related disaster that chills enthusiasm for the field, while greater regulatory convergence could help tamp down the proliferation of stem cell clinics, the FDA’s Peter Marks says.

Mole hills
Like mole hills in a yard, stem cell clinics are popping up all over the world due to a lack of uniform regulatory oversight, FDA's Marks says. • Source: Shutterstock

Regulatory strengthening in middle- and lower-income countries is critical to ensuring public confidence in gene and cell therapies on an international scale, the US Food and Drug Administration’s Peter Marks believes.

Marks, director of the Center for Biologics Evaluation and Research, also said increased international convergence on cell and gene therapy regulation and oversight will go a long way toward

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