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

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.

Two final guidance documents released on 29 January, “Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products” and “Human Gene Therapy Products Incorporating Human Genome Editing,”

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