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US FDA Project Protect Oncology Safety Program In Broad Use After Quiet Launch

 
• By Kate Rawson

Project Protect is the Oncology Center of Excellence’s latest program to support cancer drug development; the safety signal tool has been used to support 44 drug applications.

Cancer cell
Project Protect, which is aimed at oncology drug safety, already has been used to support 44 applications. • Source: Alamy

The US Food and Drug Administration quietly unveiled yet another Oncology Center of Excellence “project.” This one, Project Protect, is aimed at providing “consistent advice and review” of safety signals across oncology drug classes.

In what has become a familiar strategy for Director Rick Pazdur, OCE launched Project Protect without fanfare in 2021. OCE first mentioned the program in its recently released 2021

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