EC Authorizes Moderna’s COVID-19 Vaccine for European Roll-Out
The European Commission has granted a conditional marketing authorization to Moderna for its COVID-19 vaccine.
Following a positive recommendation by the European Medicines Agency (EMA), the European Commission (EC) has granted a conditional marketing authorization (CMA) to Moderna for its COVID-19 vaccine.
As a result of the decision by the EC, vaccination programs using the Moderna vaccine can now be rolled out across the European Union. With the EU, Moderna’s vaccine is now authorized for use across four jurisdictions, the others include the United States, Canada, and Israel. Authorizations for the vaccine are also currently under review in the United Kingdom, Singapore, and Switzerland.
“I want to thank the European Commission for its engagement and endorsement and the EMA for its recommendation, which is another significant moment in our company’s history,” said Stéphane Bancel, CEO of Moderna, in a Jan 6, 2021 press release. “The EMA and the Committee for Medicinal Products for Human Use reviewers, working over the holidays, provided a thorough review and comprehensive guidance as we worked together to achieve this authorization. I am proud of the role Moderna has been able to play globally in helping to address this pandemic.”
Source: Moderna
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
AES Clean Technology Launches Next-Generation OSM Utility Solution for Cleanrooms at INTERPHEX 2025
April 2nd 2025Officially launched at INTERPHEX 2025, the Omni ASCENT is a next-generation off-site manufactured vertical utility solution that offers optimized cleanroom flexibility and efficiency.
