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BioWorld - Wednesday, December 10, 2025
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Home » Industry supports most TGA proposals for CDx regs but seeks clarity
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Industry supports most TGA proposals for CDx regs but seeks clarity

July 15, 2019
By Tamra Sami
PERTH, Australia – The majority of comments were positive for the Therapeutics Goods Administration's proposal for regulating in vitro diagnostic companion diagnostics (IVD CDx) to ensure the devices receive appropriate premarket scrutiny. Currently, Australia does not have a framework for companion diagnostics. Until now, the TGA has assessed the associated therapy and companion diagnostic separately, which does not always allow comprehensive evaluation of the benefits and risks of using the therapy and device together, the TGA said.
BioWorld MedTech Regulatory Diagnostics Asia-Pacific Australia TGA

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