You can listen to available guidance podcasts at this link.
| Date | Title of guidance and link to document | Type and level of guidance | About the guidance |
|---|---|---|---|
| 1 Jul 2026 | Submitting Next-Generation Sequencing Data to the Division of Antiviral Products | Final, Level 2 | 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. |