News for hackers. Stuff that matters.
Re:Pfizer Covid vaccine approved for use next week in UK by MauranKilom on Thursday December 03, 2020 @03:17PM (#25294149)
I don't know if it's different in pharmaceutics, but for medical devices it is literally all about proving a product "safe and effective".

And the FDA itself talks about approved drugs being safe and effective: https://www.fda.gov/drugs/drug-information-consumers/fdas-dr...

Re:Pfizer Covid vaccine approved for use next week in UK by refurb on Friday December 04, 2020 @07:00AM (#25301370)
It might be a matter of "do as I say, not as I do". If you look up prior FDA violations, you'll see the FDA get pretty ticked about not clearly laying out the safety risks of a medication - as such, using language such as "our drug is safe" would go directly against that.

The FDA is incredibly strict when it comes to advertising. I remember reading about one violation where the ad had a tagline for an ADHD medication "So you can concentrate on the important things" and showed a picture of a child studying. The FDA said "the image implies that your medication will improve the ability of a child to study and you have submitted no data to the FDA to support this claim".