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Quality Issues Star In US FDA Complete Response Letter Trio

 
• By Bridget Silverman

Rocket Pharmaceuticals’ gene therapy Kresladi, Daiichi Sankyo/Merck’s patritumab deruxtecan, and AbbVie’s foscarbidopa/foslevodopa (ABBV-951) received CRLs because of manufacturing concerns.

drug manufacturing
Three FDA CRLs disclosed this week included manufacturing problems. • Source: Shutterstock

In an unusual move, three US Food and Drug Administration complete response letters related to manufacturing issues were announced in the same week, all relating to very different products: a gene therapy, an antibody-drug conjugate (ADC), and a prodrug/device combination.

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