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Insight & Intelligence : Oct 19, 2011
FDA Details Requirements for Regulatory Submissions of Genomic Biomarkers
Agency hopes efforts to streamline biomarker development will advance more into the clinic.
FDA’s final guidance for biomarkers related to the development of new drugs or biotechnology products represents the strongest effort made by the agency to date to bring more biomarkers beyond the laboratory to the clinic. The guidance seeks also to help U.S. companies develop biomarkers for the global industry.
Spelling Out Context and Structure
Under FDA’s new biomarker guidance, descriptions of the context for using a biomarker should include: (1) the general area, (2) specific biomarker use, and (3) critical parameters that define when and how the biomarker should be used. General area includes but isn’t limited to pharmacology, toxicology, efficacy, safety, and disease.
In its final biomarker guidance, FDA used the definition of genomic biomarker developed by the International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use: a measurable DNA and/or RNA characteristic that is an indicator of normal biologic processes, pathogenic processes, and/or response to therapeutic or other interventions.
The discussion of biomarkers in the guidance is consistent with the “fit-for-purpose” framework for a performance-and-purpose based classification of biomarkers discussed in scientific literature in recent years, Antoinette F. Konski, also a partner with Foley & Lardner, and a member of the firm’s chemical, biotechnology, and pharmaceutical practice, explained to GEN.
Alex Philippidis is senior news editor at Genetic Engineering & Biotechnology News.
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