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Regulatory NEWS

The FDA co-development draft guidance for companion diagnostics and their associated therapeutics tackled a largely novel area of regulatory science for the practice of 21st Century medicine, but a webinar clarified that a CDx need not be a market-ready test.

PERTH, Australia – Drug manufacturers with operations in Australia will have four years to transition to new labeling requirements for medicines in Australia.

With just a few months to go, the FDA’s drug center is still hoping to push out more than 100 new and revised draft guidances before the year ends and a new administration comes on board.

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