Bioassay Instructions For Tests Using Rats Provided To Bolster US Infant Formula Supply

Draft details modifications to AOAC International’s PER rat bioassay method to show a formula meets quality factor of sufficient biological quality of protein, one factors FDA considers in evaluating submissions.

Draft guidance on designing, conducting, evaluating and reporting studies using rats and the Protein Efficiency Ratio (PER) bioassay merthod is the Food and Drug Administration’s latest move to strengthen the US infant formula supply chain.

The draft guidance announced on 9 February is intended to build “a more resilient infant formula industry” by helping...