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29 Jun 2015

What is A breakthrough therapy and Breakthrough Therapy Designation?

On July 9, 2012 the Food and Drug Administration Safety and Innovation Act (FDASIA) was signed.

FDASIA Section 902 provides for a new designation -.  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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