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Candidates For The US FDA’s STAR Program Might As Well Be Breakthrough Therapies, Too

 
• By Derrick Gingery

The requirements to join the new real-time review pilot program strongly resemble those of the breakthrough designation, which could come as an unpleasant surprise for some sponsors.

FDA website
The FDA's requirements for the STAR program are very similar to the breakthrough therapy designation. • Source: Shutterstock

Sponsor excitement about the US Food and Drug Administration expanding the real-time oncology review program to other therapeutic areas may be tempered by the requirements to join, which strongly resemble another expedited review program.

Mary Thanh Hai, deputy director for clinical in the FDA Office of New Drugs, said sponsors likely would have to be able to obtain a breakthrough therapy designation in order...

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More from Pathways & Standards

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