3 ms·

Very interesting and good to hear. So drug companies are sharing early trial data with the FDA?

mlyle 6y ago
Trial design and trial data are shared with the FDA underway during an ordinary drug or device trial. But applications subject to FDA Fast-Track authorization processes also undergo "rolling review" where portions of the new drug application are reviewed as they are partially complete. This has narrowed the set of action items that remain. I'm sure a lot of people are staying up late as the EUA applications come in, and skimming the documents and working to identify remaining weaknesses that can be proactively addressed. But sometime in this, they need to get a good night's sleep, and begin meticulously going through the document and make sure the remaining, necessary (i.e. not waived) conditions for emergency use approval are met.
- 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 ago
    Googling '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 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 ago
        Sure, 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.

Trial design and trial data are shared with the FDA underway during an ordinary drug or device trial. But applications subject to FDA Fast-Track authorization processes also undergo "rolling review" where portions of the new drug application are reviewed as they are partially complete. This has narrowed the set of action items that remain. I'm sure a lot of people are staying up late as the EUA applications come in, and skimming the documents and working to identify remaining weaknesses that can be proactively addressed. But sometime in this, they need to get a good night's sleep, and begin meticulously going through the document and make sure the remaining, necessary (i.e. not waived) conditions for emergency use approval are met.

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 ago
  Googling '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 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 ago
      Sure, 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.