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Overcoming Bias Commenter's avatar

I have friends who work in the Canadian equivalent of the FDA. They actually run their inspections differently from the FDA, on purpose, to cover off things that the FDA might miss.

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Overcoming Bias Commenter's avatar

Since approvals are made by national agencies, nationally aggregated incentive determines willingness to fund the (expensive) review process. The U.S. is often the largest market in sales and patients and places high valuations on life and thus has the highest aggregated incentive to fund "correct" decisions. Under a policy that the FDA would accept approval in certain other countries, drug companies would have a strong incentive to find the review agency with the least ability to stage a critical review. It probably won't be the U.S FDA.

So yes, I might know better than Billy's parents if I have more time and money to spend investigating.

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