rdf-syntax-grammar
mods:
  schema location: http://www.loc.gov/mods/v3 http://www.loc.gov/standards/mods/v3/mods-3-2.xsd
  title info:
    title: FDA Guidance Regarding the Promotion of Off-Label Uses of Drugs
    sub title: Legal Issues
  name:
    name part: Library of Congress
    name part: Congressional Research Service.
    role:
      role term: creator
  name:
    name part: ProQuest (Firm)
  type of resource: text
  genre: Electronic books.
  origin info:
    place:
      place term: dcu
    date issued: 2009
    issuance: monographic
  language:
    language term: eng
  physical description:
    reformatting quality: preservation
    form: remote
    extent: 1 online resource.
  abstract: Reviews FDA guidance regarding promotion of off-label drug use. Summarizes relevant provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA) and related regulations that have been used to address misbranding violations of FFDCA that relate to pharmaceutical manufacturer promotion of off-label use; FDA previous off-label marketing provisions under the Food and Drug Administration Modernization Act (FDAMA) of 1997, which are no longer in effect; and Jan. 2009 guidance document and its similarities to and differences from the FDAMA provisions. Outlines First Amendment challenges to FDAMA and older FDA guidance documents addressing off-label promotion. Discusses nature of guidance documents, in contrast to rules promulgated under the Administrative Procedure Act, as well as administrative law issues associated with FDA issuance of the guidance. Provides overview of the False Claims Act and related qui tam cases that addressed off-label marketing practices of pharmaceutical companies, and analyzes interaction of the new guidance document and the FCA.
  note: Record is based on bibliographic data in ProQuest U.S. Congressional Research Digital Collection (last viewed Dec. 2010). Reuse except for individual research requires license from ProQuest, LLC.
  note: CRS Report.
  note: Electronic resource.
  subject:
    geographic code: n-us---
  subject:
    topic: Administrative law
  subject:
    topic: Drugs
  subject:
    topic: Freedom of speech
  related item:
    title info:
      title: FDA Guidance Regarding the Promotion of Off-Label Uses of Drugs
    name:
      name part: Library of Congress. Congressional Research Service.
  related item:
    title info:
      title: U.S. Congressional Research
  identifier: http://proxy.library.tamu.edu/login
  record info:
    record content source: ProQuest
    record creation date: 101221
    record change date: 20260605134205.2
    record identifier: in00003410803