Aztreonam-avibactam, Pfizer/AbbVie’s candidate for treating multidrug-resistant infections, and mRNA-1345, Moderna’s investigational respiratory syncytial virus (RSV) vaccine for older adults, are the first two products to be earmarked for review under the European Medicines Agency’s newly extended OPEN framework for collaboratively assessing marketing applications with non-EU authorities.
Key Takeaways
- The European Medicines Agency's newly extended OPEN framework provides for near-concurrent review of drug marketing applications by one or multiple additional regulatory authorities, each conducting their own assessment in parallel to the EMA evaluation while sharing scientific expertise and maintaining their scientific and regulatory independence.
- The framework has the potential to achieve faster overall global approval of a product, according to the EMA
Switzerland’s drug regulator, Swissmedic, will be involved in the OPEN initiative as part of the review of
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Pink Sheet for daily insights
- Start your 7-day free trial
- Explore trusted news, analysis, and insights
- Access comprehensive global coverage
- Enjoy instant access – no credit card required
Already a subscriber?