Computerized Systems Guide a Go at FDA.

  • Bleicher P
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Abstract

The author comments on the decision of the U.S. Food and Drug Administration to release the final Guidance for Computerized Systems Used in Clinical Investigations in the U.S. He states that the new regulation will represent a thoughtful step toward creating a workable environment for the development and deployment of computerized systems in clinical trials. He anticipates that these rules will reveal the difficulties and deficiencies in the existing technology used in clinical trials.

Author-supplied keywords

  • MEDICAL innovations
  • MEDICAL policy
  • MEDICAL technology
  • UNITED States
  • UNITED States. Food & Drug Administration

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Authors

  • Paul Bleicher

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