Notice of Decision Not To Designate Hepatitis Delta Virus Diseases as an Addition to the C
In response to a suggestion by Gilead Sciences, Inc. (Gilead) that was submitted to the public docket FDA-2008-N-0567 on February 14, 2022, the Food and Drug Administration (FDA or Agency) has analyzed whether hepatitis delta virus (HDV) infection meets the statutory criteria for designation as a "tropical disease" und
| Agency | Health and Human Services Department, Food and Drug Administration |
|---|---|
| Document type | Notice |
| Published | 2026-05-22 |
| Summary | In response to a suggestion by Gilead Sciences, Inc. (Gilead) that was submitted to the public docket FDA-2008-N-0567 on February 14, 2022, the Food and Drug Administration (FDA or Agency) has analyzed whether hepatitis delta virus (HDV) infection meets the statutory criteria for designation as a "tropical disease" under Section 524 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, the Agency has analyzed whether there is "no significant market in developed nations" for drugs for HDV infections and whether HDV "disproportionately affects poor and marginalized populations," both of which are statutory criteria for designation as a "tropical disease." At this time, the Agen |
| Document number | 2026-10268 |
| Official record | https://www.federalregister.gov/documents/2026/05/22/2026-10268/notice-of-decision-not-to-designate-hepatitis-delta-virus-diseases-as-an-addition-to-the-current |