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FDA Stays Parts of Guidance on Clinical Research Involving Foods
date:Nov 06, 2015
ts of subsection VI.D.

While the partial stay is in effect, researchers and sponsors of studies that are intended to support a new or expanded health claim and conducted in healthy individuals over 12 months of age do not need to obtain an IND. Researchers and sponsors of studies regarding non-nutritional effects of conventional foods on the structure or function of the body also do not need to obtain an IND while the stay is in effect.

FDA has republished the final guidance with the stayed po

07/11 05:14