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GUIDANCE DOCUMENT

Submitting Next-Generation Sequencing Data to the Division of Antiviral Products July 2026

Download the Final Guidance Document
Final Level 2 Guidance
Docket Number:
FDA-2017-D-6821
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The purpose of this technical specifications document is to provide the current thinking of FDA’s Division of Antivirals (the Division) regarding the submission of next-generation sequencing (NGS) protocols, data, and analyses in support of resistance assessments for the development of antiviral drugs. 

The Division performs independent analyses of all NGS data associated with antiviral drugs under development, including small molecule and immunoglobulin-based drugs, to ensure that drug resistance is carefully characterized and explained in the labeling of approved antiviral drugs. Providing comprehensive and accurate resistance information is important to inform resistance surveillance efforts, monitor the emergence of novel drug-resistant viral variants, and protect public health. In addition, the resistance information provides important guidance for health care professionals who prescribe antiviral drugs.

Submit Comments

Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2017-D-6821.

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