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0 pointsProjectArcturis1y ago0 comments

This is false. The FDA does not grant approval to market anything solely on the basis of "low risk for adverse events." The game makers had to run studies demonstrating that it improved ADHD measures. The link you provided says that as well:

"The FDA reviewed data from multiple studies in more than 600 children, including studies that evaluated, among other things, whether participants demonstrated improvements in attention function, as measured by the Test of Variables of Attention (TOVA), academic performance measures, and other assessment tools."

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gcheong1y ago

Fair enough, I think I came to that conclusion because reading the next statement was just that they determined there were no major adverse events. But I think it still stands that this is only a marketing authorization, the FDA isn't saying it works, so really the company shouldn't be mentioning the FDA at this point unless they go for a stronger classification.

ProjectArcturisOP1y ago

"When the facts change, I don't change my opinion."

gcheong1y ago

Which facts? I was wrong about the evidence needed for marketing authorization but, if I’m not mistaken, they would need that authorization in order to market the product in the first place so mentioning the FDA authorization would, in my opinion, potentially give people the wrong impression that the FDA has endorsed the product at a level (e.g. approval) which I don’t believe the FDA has done at this point.

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0 pointsProjectArcturis1y ago0 comments

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gcheong1y ago

ProjectArcturisOP1y ago

"When the facts change, I don't change my opinion."

gcheong1y ago

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