The U.S. Food and Drug Administration (FDA) has issued final guidance for manufacturers of infant formula and laboratories conducting testing on infant formula.

The guidance was developed to help manufacturers and laboratories in the design, conduct, evaluation, and reporting of Protein Efficiency Ratio (PER) studies. PER studies are used to assure the quality of the protein in infant formulas.

The guidance is intended to help industry, particularly those looking to introduce new infant formula to the U.S. market, by outlining how PER studies can be conducted to meet FDA’s requirement that a new infant formula meets the quality factor of sufficient biological quality of protein.