Regulatory Watch: Evaluating the Potential for Digital Submission of Expedited Premarket Safety Reports to the FDA

Nat Rev Drug Discov. 2016 Sep 29;15(10):670-1. doi: 10.1038/nrd.2016.189.

Publication types

  • News

MeSH terms

  • Computers / standards*
  • Computers / trends
  • Device Approval / standards*
  • Drug Approval*
  • Humans
  • Research Report / standards*
  • Research Report / trends
  • Safety
  • United States
  • United States Food and Drug Administration / standards*
  • United States Food and Drug Administration / trends