FDA BRIEF: Week of Feb 19, 2018


CaptureCDER Warning Letters

Provided by CDER Freedom of Information Office (FOI)

  • Some have been redacted or edited to remove confidential information
  • Matters may have been subject to subsequent interaction between FDA and the recipient that may have changed the regulatory status

Types of Letters

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PDUFA VI Information Technology Goals and Progress

Goal of improving predictability and consistency of electronic submission process

  • Electronic Submission Documentation
  • Electronic Submission and System Status
  • Electronic Submission Gateway (ESG) Target Timeframes, Milestones and Notifications

Enhance transprency and accountability of electronic submission and data standards activities

  • IT Public Meetings
  • Electronic Submissions Performance Metrics
  • Data Standards

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Image credit: FDA

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