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

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 drugs from coming to market.

CDRH 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

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