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Companion Diagnostics For Breakthrough Drugs Also Getting Swift Attention, FDA Says

 
• By Sue Sutter

Device center officials cite a host of formal and informal actions available under existing legislative authority to ensure that development and review of companion diagnostics do not hinder the ability of FDA-designated breakthrough therapies from coming to market.

FDA’s Center for Devices and Radiological Health is using its regulatory flexibility to ensure that development and evaluation of companion diagnostics for “breakthrough” therapies keep pace with the speedier timelines envisioned for such drugs under the FDA Safety and Innovation Act.

Speaking at a Sept. 6 conference on drug/diagnostic co-development for breakthrough therapies, CDRH officials highlighted a number of formal and...

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