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According to the FDA the question they want to answer at a new drug approval is: "Does this drug work for the proposed use?" To answer that question the FDA requires the drug company to submit studies that prove the drug to be safe and effective for the proposed use. There are a host of criteria's such as preregistration that the FDA takes into account but ...


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Yes, and the problem exists across many areas of science The problem of reproducibility is attracting a lot more attention. A recent Nature News Feature discusses the possible causes of bad results in the literature and many examples where they have been exposed. Its headline sums up the problem: Humans are remarkably good at self-deception. But growing ...


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Yes, it's known that some drugs work, but how they work is unknown. For example, acetaminophen (a.k.a. paracetemol). MedScape explains: The exact mechanism by which acetaminophen produces its analgesic and antipyretic effects remains undefined. Wikipedia explains the general case as "unknown mechanism of action". These drugs are FDA approved because it'...


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You don't have to look far to find examples of major classes of drug where we don't have a good knowledge of how they work. One of the earliest "modern" medical advances was anaesthetics, first used in 1842 to transform surgery. Despite using them for a century and a half, medicine is still debating exactly how they work. There is an excellent summary on ...


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