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HONG KONG – Chinese regulators have clarified the legal consequences of data falsification in new drug and medical device applications, alarming the industry – both applicants for registration and research institutions – by raising falsification to the level of a criminal law violation.

The FDA Reauthorization Act of 2017 sailed through a final Senate vote of 94-1 despite a drawn-out cloture vote.

PERTH, Australia – Australia's Therapeutic Goods Administration is asking for industry feedback on whether Australia should change its naming mechanisms for biosimilars and biologics and if it should adopt practices of other international regulators.

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