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Public Health 17 , 659 (2020)

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Once FDA establishes the intended use, FDA can review its own records to determine that the company is not registered with FDA and/or has no drug approval, at which point the product is an unapproved new drug. Adulteration and misbranding violations follow in line, both of which are based on statutes carrying civil and criminal penalties

Blinding and allocation concealment are often inadequately reported, increasing the risk of bias

These help keep children regulated before assessments

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