> Yes, they will have to go through health and safety trials for each additional vaccine developed using this technology. No one gets special treatment when it comes to FDA approval, and this is the way it should be.
true, but there are loopholes. the 510(k) loophole for medical devices where any device that is "substantially equivalent" to an existing approved device can get fast track approval has proved problematic. this has been publicly documented both in the press and in independent documentaries for some time.
true, but there are loopholes. the 510(k) loophole for medical devices where any device that is "substantially equivalent" to an existing approved device can get fast track approval has proved problematic. this has been publicly documented both in the press and in independent documentaries for some time.
https://www.fda.gov/medical-devices/premarket-submissions/pr...