Birdwatch Note Rating
2023-05-05 03:22:07 UTC - HELPFUL
Rated by Participant: 4558DB0D99221AEE82AF0B34EAC65BA7D744D0FBF24E1BC6F82204DE578BE405
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