A pilot study of electronic submission of periodic reports to the FDA: Flexible diskette submission-glaxo program development

Academic Article

Abstract

  • A prototype program in which adverse event data is submitted to the FDA using floppy diskettes is described. The steps necessary to convert data from the company's database into a format readable by the FDA's computer system is described. Potential future applications of this technology are also discussed. © 1988, Drug Information Association. All rights reserved.
  • Authors

    Digital Object Identifier (doi)

    Author List

  • Dobbs JH
  • Start Page

  • 59
  • End Page

  • 60
  • Volume

  • 22
  • Issue

  • 1