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8 May 2015

What is USFDA’s Breakthrough Therapy Designation?

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As per the FDA, Breakthrough Therapy Designation is aimed at accelerating the development and review of drugs for life-threatening conditions. Breakthrough Therapy Designation criteria consists of preliminary clinical evidence showing that a drug could have considerable improvement on at least one clinically significant final stage of the process compared to available therapy.

A breakthrough therapy is a drug:

  • intended alone or in combination with one or more other drugs to treat a serious or life threatening disease or condition and
  • preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.
If a drug is designated as breakthrough therapy, FDA will expedite the development and review of such drug.  All requests for breakthrough therapy designation will be reviewed within 60 days of receipt, and FDA will either grant or deny the request.

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