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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

The therapeutic landscape weighs heavily in the US Food and Drug Administration’s evaluation of the diligence with which accelerated approval sponsors conduct confirmatory trials and whether those drugs should be removed from the market.

The FDA’s focus on the therapeutic landscape repeatedly was emphasized during the 16 November Oncologic Drugs Advisory Committee meeting on...

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AMR-Targeting Drug Secures EMA PRIME Designation

 
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Global Pharma Guidance Tracker - April 2025

 
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Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

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