Notes on RPS Version 2 Working Group Meeting
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.