FDA released a final guidance - one with technical specifications on "Submitting Next-Generation Sequencing Data to the Division of Antivirals". The Agency notes that it does its own analysis and why: "The Division performs independent analyses of all NGS data associated with antiviral drugs, including small molecule and immunoglobulin-based drugs, under development to ensure that drug resistance is carefully characterized and explained in the label of approved antiviral drugs." Having the data in consistent and reliable formats ensures their ability to expeditiously complete their analysis. In addition to covering the data file formats and how to submit, the guidance covers the sponsor data analysis and reporting in clinical study reports, naming conventions, and example tables.
https://www.fda.gov/media/129126/download
#NGS #FDAsubmission #antiviral
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Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]Bioanalytical Solution Integration
LinkedIn:
https://www.linkedin.com/in/markearnoldphd/Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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