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FDA’s Breakthrough Designations Face Question Of Review Resources

 
• By Derrick Gingery

Woodcock says FDA will manage breakthrough applications along with its entire portfolio of submissions, but some stakeholders express concern about whether the demands of the exceedingly popular program will affect the agency’s handling of other applications.

FDA is facing questions about whether the growing number of breakthrough designations has pulled resources away from other applications, an indication there may be concerns about the demands the program is placing on the agency.

A breakthrough designation allows the product sponsor easier and more-frequent interaction with FDA officials and streamlined development, if early clinical evidence indicates a major improvement over existing therapy.

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