Next-Generation Sequencing Data Submission Guidance

FDA has published a guidance, Submitting Next-Generation Sequencing Data to the Division of Antivirals, with the agency’s current thinking about the submission of next-generation sequencing (NGS) protocols, data, and analysis supporting resistance assessments for developing antiviral drugs. The document says the provision of comprehensive and accurate resistance information is imperative to inform resistance surveillance efforts, monitor the emergency of novel viral variants that are resistant to approved antiviral drugs, and protect public health. In addition, it says, the resistance information provides guidance for healthcare professionals who prescribe antiviral drugs and is included in the drug product information approved by the division.

The guidance includes an Introduction, Acceptable NGS Platforms, Summary of Information to Submit to the Division, NGS Protocol, NGS Report, NGS File Types and Submission Procedures, and Amino Acid Frequency Table Example.