title: Emergency Use Authority and 2009 H1N1 influenza.
abstract: This article discusses the steps that the Department of Health and Human Services follows to authorize emergency use of products under section 564 of the Federal Food, Drug and Cosmetic Act through Emergency Use Authorizations. We provide examples of when the department might authorize such emergency use and describe the products for which the department has authorized emergency use for the current H1N1 influenza pandemic as of September 1, 2009.
authors.affiliation: Office of the General Counsel, U.S. Department of Health and Human Services, Washington, DC 20201, USA. Susan.Sherman@hhs.gov
authors.forename: Susan E
authors.initials: SE
authors.lastname: Sherman
authors.forename: Joseph
authors.initials: J
authors.lastname: Foster
authors.forename: Sonal
authors.initials: S
authors.lastname: Vaid
mesh_terms: D000998:Antiviral Agents; D004630:Emergencies; D006801:Humans; D053118:Influenza A Virus, H1N1 Subtype / Q000187:drug effects; D007251:Influenza, Human / Q000188:drug therapy; D016134:Organizational Policy; D012134:Respiratory Protective Devices; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000998:Antiviral Agents