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FDA Electronic Submission Gateway: Impact of the Gateway

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  1. The Gateway can have a positive impact on many existing practices:
    • Time efficiency is greatly increased, and same-day delivery becomes possible.
    • The number of paper copies generated for submission and archiving is dramatically reduced.
    • WebTrader transmissions can replace media creation with minimal impact and with no additional resources required.
    • Electronic acknowledgments of successful transmission can be received and saved.
    • Shipping expenses are eliminated or greatly reduced.
  2. Implementing the Gateway requires some process changes:
    • Some new roles (see item 3) are necessary.
    • New administrative tasks are created:
      • Establishing webtrader accounts
      • Obtaining digital security certificates
    • The archive process must be modified.
    • Technical issues must be addressed as they arise.
  3. The following staff and training are needed to develop a workable process with the Gateway in your company:
    • Gateway specialists must be chosen and trained.
    • Specific staff involved (limited training needed):
      • Regulatory Operations
      • Regulatory Affairs
      • Information Technology
      • Archive
    • SOPs and working practices must be created or modified

 

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Page Last Updated: 12/30/2014
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