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FDA Stays Parts of Guidance on Clinical Research Involving Foods
date:Nov 06, 2015
ould negatively affect parts of the dairy industry, particularly yogurt producers.

The guidance would require studies involving conventional foods to comply with onerous investigational new drug (IND) requirements, which are designed to protect human research subjects. According to the original guidance, a product could be regulated as a drug, and thus be required to go through the IND process, merely because of the conditions studied in a clinical investigation, regardless of the actual claim

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