American Journal of Ophthalmology
Volume 143, Issue 5 , Pages 853-855 , May 2007

Does “Off-Label” Mean Off Limits for Patient Care?

  • Richard Parrish II

      Affiliations

    • University of Miami Miller School of Medicine, Bascom Palmer Eye Institute Miami, Florida
    • Corresponding Author InformationInquiries to Richard Parrish II, University of Miami Miller School of Medicine, Bascom Palmer Eye Institute, 900 NW 17th St, Miami, FL 33136
    • ,
  • Paul Sternberg Jr

      Affiliations

    • Vanderbilt Eye Institute, Nashville, Tennessee.

,Accepted 12 January 2007.

References 

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  12. Gottlieb S. Deputy Commissioner for Medical and Scientific Affairs, Food and Drug Administration, Speech before Windhover’s FDA/CMS Summit. 2006;Washington, DC, December 5. Available at http://www.fda.gov/oc/speeches/2006/windhover1205.html. Accessed Date: December 19, 2006.
  13. Legal status of approved labeling for prescription drugs; prescribing for uses unapproved by the Food and Drug Administration: notice of Proposed rule making. Fed Register. 1972;37:158
  14. Information Sheets Guidance for Institutional Review Board and Clinical Investigators 1998 Update. Available at http://fda.gov/oc/phrt/irbs/offlabel.html. Accessed Date: December 23, 2006.
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PII: S0002-9394(07)00114-6

doi: 10.1016/j.ajo.2007.01.044

American Journal of Ophthalmology
Volume 143, Issue 5 , Pages 853-855 , May 2007

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