Login to Your Account



Regulatory NEWS

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.

More Regulatory Headlines

Cast Your Vote

Should there be restrictions on the use of gene-editing technology?: