FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: PROTEIN EFFICIENCY RATIO RAT BIOASSAY STUDIES TO DEMONSTRATE THAT A NEW INFANT FORMULA SUPPORTS THE QUALITY FACTOR OF SUFFICIENT BIOLOGICAL QUALITY OF PROTEIN; GUIDANCE FOR INDUSTRY; AVAILABILITY

WASHINGTON, May 22 -- Food and Drug Administration has issued a notice called: Protein Efficiency Ratio Rat Bioassay Studies To Demonstrate That a New Infant Formula Supports the Quality Factor of Sufficient Biological Quality of Protein; Guidance for Industry; Availability.

The notice was published in the Federal Register on May 22 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA or we) is announcing the availability of a guidance entitled "Protein Efficiency Ratio (PER) Rat Bioassay Studies to Demonstrate That a New Infant Formula Supports the Quality Factor of Sufficient Biological Quality of Protein." The guidance provides information for manufac...