# Guidance for Industry: Protein Efficiency Ratio (PER) Rat Bioassay Studies to Demonstrate that a New Infant Formula Supports the Quality Factor of Sufficient Biological Quality of Protein – FDA Guidance

Source: https://www.keypedia.com/guidances/guidance-document/guidance-for-industry-protein-efficiency-ratio-per-rat-bioassay-studies-to-demonstrate-that-a-new-infant-formula-supports-the-quality-factor-of-sufficient-biological-quality-of-protein/8474a8c1-edef-459f-8adc-283fc55ccce6

> FDA guidance document: Guidance for Industry: Protein Efficiency Ratio (PER) Rat Bioassay Studies to Demonstrate that a New Infant Formula Supports the Quality Factor of Sufficient Biological Quality of Protein. Issue date: May 21, 2026. Get complete insights and analysis.

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## Details

- Title: Guidance for Industry: Protein Efficiency Ratio (PER) Rat Bioassay Studies to Demonstrate that a New Infant Formula Supports the Quality Factor of Sufficient Biological Quality of Protein
- Communication Type: Guidance Document
- Product Type: food
- Office Name: Human Foods Program
- Office URL: /offices/human-foods-program/8bff4a0b-7bed-449c-b67b-56a83c96a324
- Issue Date: 2026-05-21
- Last Changed: 2026-05-21
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2022-D-2424">FDA-2022-D-2424</a>

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