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

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