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Food and Drug Administrations (FDA) regulations on good clinical practice, which are based on ethical standards outlined in frameworks such as the Belmont Report and the Declaration of Helsinki. Advarra ensures that clinical trials comply with the U.S.
The European Medicines Agency (EMA) is similar in this regard, although interestingly, that’s not the case in the United Kingdom, where regulators are not so directly involved in assessing a challenge study beforehand. The challenge agent also has to be produced under very stringent protocols. So that's a drawback.
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Bioethics 
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