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Gene And Cell Therapy Clinical Holds Decline While Those For Drugs Hit 12-Year High

 
• By Brenda Sandburg

FDA’s Center for Biologics Evaluation and Research saw IND clinical holds for gene and cell therapies dropped to 70 in calendar year 2022, a 52% decline from 2018. Center for Drug Evaluation and Research’s total clinical holds in fiscal year 2022 were 380, the highest number in the past 12 years.

Hold sign
Number of clinical holds placed on investigational new drugs vary between FDA's drug and biologics centers • Source: Shutterstock

Despite recent scrutiny of US Food and Drug Administration clinical holds on investigational cell and gene therapies, the number of holds has declined in the last three years to 70 in calendar year 2022. That is half the number of clinical holds implemented in 2018, the highest number in the past decade.

FDA’s Center for Biologics Evaluation and Research had a total of 115 investigational new drug (IND) clinical holds in calendar year 2022, including 45 for non-cell and gene therapy

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