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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 t
by MauranKilom 6y ago
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-drug-review-process-ensuring-drugs-are-safe-and-effective https://www.fda.gov/drugs/drug-information-consumers/fdas-dr...
- refurb 6y agoIt 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".