Birdwatch Note Rating
2023-05-05 00:19:27 UTC - HELPFUL
Rated by Participant: B0FFB4D99C08A78F7A5D5CEEFE5F703D963A8586A8E8BB6A614C1B7998F0D6B0
Participant Details
Original Note:
A company seeking a BLA (full approval) for its product must demonstrate that the product is “safe, pure, and potent,” which generally means completing robust, well-controlled clinical trials. COVID-19 vaccine clinical trial endpoints were met. https://blog.petrieflom.law.harvard.edu/2021/06/15/whats-the-difference-between-vaccine-approval-bla-and-authorization-eua/ https://www.law.cornell.edu/cfr/text/21/601.2 https://www.nejm.org/doi/full/10.1056/nejmoa2034577
All Note Details