EMA Considering Guideline On Evaluating Novel Antivirals for Influenza
The European Medicines Agency has identified a host of problems companies face in developing novel antiviral agents for treating influenza. It aims to clarify EU regulatory expectations on these issues through a new guideline that could be ready for consultation in Q1 2018.
You may also be interested in...
Companies are being encouraged to become “early adopters” of the EU Clinical Trials Information System when it goes live in December 2021.
Drug companies will be able to “play around” with the new EU Clinical Trials Information System in a secure testing environment before it goes live in approximately 15 months.
The Canadian authorities have put in place an expedited pathway for authorizing new COVID-19 drugs and vaccines that offers a more agile approach to reviewing data than what was previously allowed.