FDA discusses measures to avoid failures with new industry fees plan
This article was originally published in Scrip
Executive Summary
The US FDA is pressing on with efforts to gather input on how its next prescription drug user fee programme should be framed and consider how performance failures associated with its current user fee programme, PDUFA IV, can be avoided.
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.