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Product Differences Necessitate Some US FDA Inconsistency In Rare Diseases, Center Directors Say

 
• By Derrick Gingery

Development standards for a one-time gene therapy should be different from a drug taken regularly, CBER Director Peter Marks says.

Consistency arrows
Inconsistency is not the same as scientific disagreement, CDER Director Patrizia Cavazzoni said. • Source: Shutterstock

Rare disease treatment sponsors and advocates may prefer all US Food and Drug Administration teams give the same development advice, but that may not be possible across all classes of products, regulators caution.

Inconsistent advice not only occurs within the FDA’s drug and biologic offices, but between the centers. Center for Biologics Evaluation and Research Director Peter Marks said some of that inconsistency...

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