The U.S. Food and Drug Administration (FDA) has issued draft guidance to manufacturers of infant formula and laboratories conducting testing on infant formula to help them in the design, conduct, evaluation, and reporting of Protein Efficiency Ratio (PER) rat bioassay studies. Sufficient biological quality of protein is one of many factors FDA considers in evaluating a new infant formula submission. Protein quality is important as infant formula is often a sole source of nutrition, including protein, for infants.
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