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FDA Offers Technical Specifications for Submitting NGS Data on Antivirals

Posted 18 July 2019 | By Zachary Brennan 

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.

“Submissions of sequence data must include a thorough description of the analysis pipeline used to analyze the sequencing dataset and the raw sequence information so that the Division can conduct an independent analysis of the data,” the guidance explains.

FDA also discusses general protocol design elements and sample preparation “so that the sample being sequenced is representative of the population being analyzed.”

As far as contig and mapping reports, FDA adds: “Two approaches can be used for NGS analyses of data to support the development of antiviral drug products: (1) mapping of short reads to a references sequence or (2) de novo assembly of short reads to assemble contigs.”

The document also features a frequency table example and explains the file type and submission procedures.

Submitting Next Generation Sequencing Data to the Division of Antiviral Products: Guidance for Industry Technical Specifications Document

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