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Gene/Cell Therapies: Sponsors Must Plan For Long-Term Safety Follow-Up Even If They Fold

 
• By Sue Sutter

In final guidance documents on development of CAR-T cell products and human genome therapies incorporating genome editing, US FDA says that sponsors should plan for continued follow-up, with funding, even if they cease operations or withdraw the IND.

Going out of business
FDA is trying to head off lost follow-up due to a sponsor shutting down. • Source: Shutterstock

Gene and cell therapy product sponsors should have a plan for ensuring that long-term safety follow-up is completed even if they go out of business, the US Food and Drug Administration said.

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More from Advanced Technologies

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