FDA CBER Publish E16 Genomic Biomarkers Draft Guidance: Context, Structure and Format of Qualification Submissions
Full Guidance Here
The guideline describes recommendations regarding context, structure, and format of regulatory submissions for qualification of genomic biomarkers, as defined in ICH E15. Biomarker qualification has not been covered in any ICH guideline. Qualification is a conclusion that the biomarker data submitted support use of the biomarker in drug discovery, development or post-approval and, where appropriate, in regulatory decision-making. The objective of the guideline is to create a harmonized structure for the qualification of genomic biomarkers that will foster consistency of applications across regions and facilitate joint discussions with and among regulatory authorities. It is also expected that the proposed document format will, where appropriate, facilitate incorporation of genomic biomarker data into specific product-related applications. Biomarker qualification can take place at any time during drug discovery, development or the post-approval period. For those instances where it is appropriate, general guidance for inclusion of biomarker qualification data into the Common Technical Document for the Registration of Pharmaceuticals for Human Use (CTD) format marketing authorization applications is provided in this document. The use of the CTD format would be expected when biomarker data are submitted as part of an NDA or MAA or upon request by the regulatory authorities.
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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
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