FDAnews Drug Daily Bulletin
Pharmaceuticals / Research and Development

FDA Guidance Provides Advice on Validating Tests for Protein Products

April 29, 2016

The FDA is providing updated guidance on assessing the effects of protein-based treatments on the immune system, offering advice on how to validate results but little new information on testing protocols.

In a revised draft guidance issued last week, the agency takes a radical departure from its 2009 version, better wedding it to 2014 companion guidance on assessing immunogenicity of therapeutic protein products.

Specifically, the agency provides details intended to help in testing protein-derived products, such as insulin, as well as determine whether these products trigger adverse immune responses in patients. The document also sets parameters for validating the testing methods, which is where most of the changes lie.


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