FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: NOTICE OF DECISION NOT TO DESIGNATE HEPATITIS DELTA VIRUS DISEASES AS AN ADDITION TO THE CURRENT LIST OF TROPICAL DISEASES IN THE FEDERAL FOOD, DRUG, AND COSMETIC ACT

WASHINGTON, May 22 -- Food and Drug Administration has issued a notice called: Notice of Decision Not To Designate Hepatitis Delta Virus Diseases as an Addition to the Current List of Tropical Diseases in the Federal Food, Drug, and Cosmetic Act.

The notice was published in the Federal Register on May 22 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

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...