Aus Clinical Evidence Guidance Tackles 'Leading Cause' Of Medtech Rejections
This article was originally published in Clinica
Executive Summary
Australia's Therapeutic Goods Administration is seeking to clarify for medical device makers its expectations for clinical evidence, the inadequacy of which has apparently been a leading cause of rejection of registration applications in the country, especially for higher risk devices.
You may also be interested in...
New EU Approvals
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add two new products, including Ryzneuta, Evive Biotechnology's treatment for chemotherapy-induced neutropenia.
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.
EU CHMP Opinions And MAA Updates
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.