Australia Consults On Stricter Rules For Personalized And 3D-Printed Devices
Executive Summary
The strict regulatory oversight that applies to conventionally produced implants would also start applying to similarly high-risk 3D printed implants under new proposals from Australia's Therapeutic Goods Administration.
You may also be interested in...
Australia Tries Again At Tightening Personalized And 3D-Printed Device Rules
The Therapeutics Goods Administration has begun a second public consultation on how it intends to improve its rules for 3D-printed and other personalized medical devices after stakeholders called for more clarification to proposals made in 2017.
Canada Makes Headway On Pilot To Test E-Submission Gateway; Guidance For 3D-Printing
Canada will test the feasibility of receiving structured regulatory information from medical device sponsors through its common electronic gateway. Separately, a draft guideline on 3D-printed devices is in the works and is expected to be issued for consultation later this year.
Outlook Turns To Marketing Strategy After Scoring EU First For Ophthalmic Bevacizumab
Outlook Therapeutics’ intravitreally injected Lytenava has won the thumbs up from the European Medicines Agency. The company is assessing both direct commercialization of the product and partnering in Europe on a country-by-country basis.