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FDA Issues New Guidelines on Clinical and Nonclinical Genomic Biomarkers

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The U.S. Food and Drug Administration (FDA) has issued new guidelines on biomarkers related to drug or biotechnology product development. The guidance was developed within the Efficacy Working Group of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

The objective of the guidance is to create a coordinated framework for biomarker qualification applications that will promote consistency of applications across regions and facilitate discussions with regulatory authorities.

The guidance includes recommendations covering the context, structure, and format of qualification submissions for clinical and nonclinical genomic biomarkers related to development of drug or biotechnology products including translational medicine approaches, pharmacokinetics, pharmacodynamics, and efficacy and safety aspects.

Although the guidance does not explicitly cover nongenomic biomarkers, according to the FDA the principles described are applicable to a variety of biomarker categories (genomics, proteomics, imaging) and other qualification contexts associated with drug or biotechnology product development.

The guidance also covers the submission of data relevant to the validation of new analytical approaches to improve the evaluation of current biomarkers. The guidance does not address either the qualification process or the evidentiary standards for a biomarker to be qualified by regulatory authorities.

Source: FDA Guidance