Accelerated Approval Drugs’ Fate Rests Heavily On Current Therapeutic Landscape When Confirmatory Trials Are Overdue

 
• By Sue Sutter

At advisory committee meeting on Acrotech's two peripheral T-cell lymphoma drugs, FDA reviewers suggest they are more willing to seek product withdrawal for failure to conduct studies with due diligence when there are numerous available therapies.

Landscape painting
FDA figuratively paints a therapeutic landscape when it considers whether to withdraw an accelerated approval drug with an overdue confirmatory trial. • Source: Shutterstock

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