Pharma guidance tracker April-May 2015
This article was originally published in SRA
Executive Summary
You may also be interested in...
EMA Reviews GSK/Vir’s COVID-19 Antibody To Support Early Use By Member States
After preliminary discussions with its pandemic task force, the European Medicines Agency has begun reviewing GSK/Vir Biotechnology’s promising COVID-19 treatment to help EU national competent authorities make evidence-based decisions on its possible early use.
Coronavirus Notebook: New EMA Review To Contextualize Blood Clot Risk From AZ Jab, EU Gets Earlier Access To More Pfizer Vaccines
Denmark has stopped using the AstraZeneca vaccine completely, while the Canadian regulator is not recommending restrictions in any specific populations. Can a new EMA review provide better context to guide the vaccine’s use in different age groups and gender?
EU Nitrosamines Oversight Group Identifies Priority Topics
After agreeing on an EU-wide harmonized approach to deal with nitrosamine contamination in medicines, a newly-created regulatory oversight group has identified several topics requiring further scientific discussion.