US, China and EU make progress on swine flu vaccines
This article was originally published in SRA
The accelerated approval process adopted by most drug regulatory authorities to allow speedier development of vaccines for the 2009 H1N1 influenza A (swine flu) virus is beginning to yield results. Yesterday, the US Food and Drug Administration announced it had approved four vaccines against the H1N1 virus1.
You may also be interested in...
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-eight guidance documents have been posted on the tracker since its last update.
New treatments for advanced endometrial cancer and hereditary angioedema are among six drugs that have just been recommended for EU-wide approval. Harmonized EU advice has also been issued in relation to an investigational antibody combination for treating COVID-19.
As part of its big data initiative, the European Medicines Agency is supporting projects that will help identify appropriate real-world data sources for regulatory decision making.