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Thanks for these links. I'm seeing that Pfizer and Moderna are participating in a rolling review in Europe, but I haven't yet found anything about that in the
by ishmandoo 6y ago
Thanks for these links.
I'm seeing that Pfizer and Moderna are participating in a rolling review in Europe, but I haven't yet found anything about that in the US. Is it automatically part of the Fast Track program?
What do press releases like these mean:
https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-submit-emergency-use-authorization https://www.pfizer.com/news/press-release/press-release-deta...
Are they announcing the _conclusion_ of the application process? It sort of presents the application as an atomic event.
- mlyle 6y agoSure, the application is an "atomic event" in both Europe and the US, even if data has been previously shared and technical assistance from the regulator has been previously offered. In the end, regulators need to give an emergency authorization or not, based on information at a certain point in time, which is also an atomic event.