3 ms·

They started rolling review back in October: https://www.pharmamanufacturing.com/industrynews/2020/uk-regulators-use-rolling-review-to-speed-pfizer-astrazeneca

• modeless 6y ago
  That's good (though it should have been earlier) but makes the approval delay even less acceptable. Edit: Actually FDA Fast Track was approved in July. There should be no surprises for the FDA in this submission. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-granted-fda-fast-track-designation-two https://www.pfizer.com/news/press-release/press-release-deta...