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Could you point me to any sort of reference on this? I'd love to update my post with this info.
by ishmandoo 6y ago
Could you point me to any sort of reference on this? I'd love to update my post with this info.
- mlyle 6y agoGoogling 'FDA fast track' yields https://www.fda.gov/patients/learn-about-drug-and-device-approvals/fast-track-breakthrough-therapy-accelerated-approval-priority-review https://www.fda.gov/patients/learn-about-drug-and-device-app... Adding 'covid' to this yields https://www.biopharma-reporter.com/Article/2020/11/10/Novavax-s-COVID-19-vaccine-gets-Fast-Track-Designation-from-FDA https://www.biopharma-reporter.com/Article/2020/11/10/Novava... etc. There's more information on the process with Europe's regulator, because they're a bit less tight-lipped than the FDA. But data sharing (particularly on adverse events) has been continually happening throughout many jurisdictions and we should see approvals in a similar timeframe between Europe and the US.
- ishmandoo 6y agoThanks 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.