Issue Date: July 1, 2026
Issued by: Center for Drug Evaluation and Research
Topic(s): Technical Specifications
Status: Final
Submitting Next-Generation Sequencing Data to the Division of Antiviral Products
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.
Download the Guidance Document
