> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Guidance on Assays for Therapeutic Protein Products
- URL: https://www.fdaweb.com/guidance-on-assays-for-therapeutic-protein-products/
- Published: 2016-04-25T12:00:00.000Z
- Updated: 2026-09-14T20:57:05.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5135488

*Federal Register* Notice: FDA is making available a revised draft guidance for industry entitled *Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products*. It provides recommendations to facilitate industry’s development and validation of immune assays for assessing the immunogenicity of therapeutic protein products during clinical trials. It applies to assays for detecting anti-drug antibodies and includes screening, confirmatory, titering, and neutralization assays. The document revises a 12/2009 draft guidance entitled *Assay Development for Immunogenicity Testing of Therapeutic Proteins*. To download this guidance, click [here](http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm192750.pdf?ref=fdaweb.com). To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-04-25/pdf/2016-09449.pdf?ref=fdaweb.com)