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US FDA’s Cell/Gene Therapy Office Looks To Improve Clarity Of Advice Through Written Responses

 
• By Sue Sutter

Standardizing the process for providing clarifications following sponsor meetings, particularly with regard to the written response-only format, is one of several solutions being piloted by the Office of Tissues and Advanced Therapies as part of its ‘growth program,’ which aims to expedite advances in cell/gene therapies while also improving staff satisfaction.

Inconsistency
FDA's Office of Tissues and Advanced Therapies is trying to improve the consistency and clarity of its advice to sponsors. • Source: Shutterstock

The US Food and Drug Administration office that oversees gene and cell therapies is piloting a series of measures aimed at improving communications and providing clearer and more consistent advice to sponsors, especially when it comes to written responses.

These “pilot solutions” include better leveraging the agency’s website to improve sponsor engagement with the Office of Tissues and Advanced Therapies, standardizing processes for sponsors to get clarifications following meetings with the agency, and working with trade

OTAT director Wilson Bryan explained the measures, which are part of the office’s “growth program,” during a session at the American Society

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