USA – FDA Offers Technical Specifications for Submitting NGS Data on Antivirals

The US Food and Drug Administration (FDA) on Thursday published a technical specifications document to help sponsors submit next generation nucleotide sequence analysis procedures and data in support of resistance assessments for the development of antiviral drugs.

The guidance explains how next generation sequencing (NGS) “adds complexity to the resistance analysis process,” which can make it challenging for reviewers “to analyze and validate the sequence information particularly because there are currently no standardized bioinformatics analysis approaches for analyzing these large datasets.”

FDA outlines what are acceptable NGS platforms and what and how information should be submitted to FDA’s Division of Antiviral Products.