Jan 13, 2021 | News, Regulatory
The European Commission (EC) announced this week that it will now be accepting remote audits during the pandemic for some European medical device and in vitro companies. The cleared pathway comes in time for upcoming deadlines in May 2021 and 2022 for the EU’s MDR...
Jul 17, 2020 | News, Regulatory
The European Commission (EC) has granted approval for Novartis’ Enzair Breezhaler, a drug therapy for uncontrolled asthma. The drug is utilized as a maintenance treatment for adults with asthma. “Novartis is working to reimagine medicine for people with uncontrolled...