Notes on RPS Version 2 Working Group Meeting

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An RPS2 Working Group meeting was held in Vancouver the week of September 15.

The working group discussed a number of business scenarios including:

  • Two Way Communication – Pre-Submission Correspondence
  • Submission Activities – Request Submission Number
  • Submission Activities – Meeting Request and Responses
  • Notification of Decision or Action
  • Request/Response for Additional information during a review cycle
  • Follow-up/Postmarket Correspondence
  • Referencing – Permit Use of Master file, Master Access File or Third Party Documentation
  • Referencing – Comparison Information
  • Referencing – Reference Information sent to an external party
  • Referencing – Paper Submission
  • Labeling Negotiations
  • Interim Actions (i.e., complete response letter, tentative approval, non-final actions, hold decisions, etc.)
  • Administrative Actions – Technical/Validation Reports/ErrorsSome of these scenarios were removed from requirements iteration #1 or merged with other scenarios.

Author: GS

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