Global Differences In Clinical Data Release Policies Cause Headaches For Sponsors
Executive Summary
A company could find itself having to create up to five different versions of its clinical study report because of the differences in regulatory policies for publishing clinical data, delegates at the recent DIA Europe 2018 conference heard.
You may also be interested in...
Califf: More Learning Necessary During Generic Drug Lifecycle
The US FDA commissioner called for enhancements to postmarketing data collection and analysis for generic drugs.
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.