Login to Your Account



Regulatory NEWS

PERTH, Australia – Australia's Therapeutic Goods Administration received mixed comments from industry on two related draft guidances for reporting adverse events for biologics and for adopting an EU guideline on good pharmacovigilance practices.

Aerie Pharmaceuticals Inc.'s claims about the efficacy of its triple-acting glaucoma drug, Rhopressa, earned uncomplicated support from FDA briefing docs published ahead of the agency's Friday DODAC meeting.

HONG KONG – China's State Council released a set of guidelines for innovation in new drug and medical device development. The new regulations round up some recent regulatory updates, providing substantial and practical guidance to further push the innovation in China's health care industry.

More Regulatory Headlines

Cast Your Vote

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