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Use of medicines outside formal regulatory drug approval, including off-label use and use of unapproved/unlicensed medicines

  • At: 2010 FIP Congress in Lisbon (Portugal)
  • Type: Presentation
  • By: MCEVOY, Gerald (American Society of Health-System Pharmacists, Bethesda, MD, United States of America)
  • Abstract:

    This presentation will focus on use of medicines outside the drug approval process. In the US and elsewhere, a drug approved for marketing usually may be labeled, promoted, and advertised by the sponsor company only for those uses for which its safety and efficacy have been established from data submitted by the sponsor and reviewed and approved

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Last update 4 October 2019

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