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Talk:Regulated Product Submission Release 2 (RPS R2) Business Scenario Development
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PARTICIPANT INSTRUCTIONS
Please use this page to discuss Business Scenarios for Regulated Product Submission. To discuss any scenario, click on the edit hyperlink for the scenario subsection. When you have finished your editing, click on the Save page button. If you wish to edit any individual scenario click on the page tab above and then click on the edit hyperlink for the section.
Please use the following etiquette for discussion purposes:
- 1. When you are adding to a discussion thread, place your input at the top, directly underneath the section heading, and use a tag to indicate who you are and when you are giving input in the format <~~~~> to insert your username and date, for example:
- <Bschoenb 20:31, 15 August 2008 (UTC)> Please consider adding X to Y...
- This will create a discussion with the most recent information at the top.
- 2. Please do not remove discussion, except if it is your own.
Topics:
- Introduction and General Topics
- Scenarios
Contents
- 1 Introduction and General Topics
- 2 Scenarios
- 2.1 Two-way Communication
- 2.1.1 Submission Activities
- 2.1.2 Meeting Requests and Responses
- 2.1.3 Follow-up/Post-market
- 2.1.4 Pre-submission Activities
- 2.1.5 Informal Interactions
- 2.1.6 Waiver Requests
- 2.1.7 Notification of Decision
- 2.1.8 Recalls
- 2.1.9 Withdraw from Market after Approval
- 2.1.10 Public Health Risk Notification
- 2.1.11 Labeling Negotiations: Request for Additional Information
- 2.1.12 Interagency Negotiations
- 2.1.13 Questions about where to find content (“I can’t find it”)
- 2.1.14 Questions from Sponsor to Agency and Resulting Response
- 2.1.15 Questions from Regulatory Authority and Sponsor Response
- 2.1.16 Identify Administrative Actions
- 2.2 Referencing
- 2.2.1 Reference Document within Submission Unit
- 2.2.2 Referencing Document between Submissions
- 2.2.3 Referencing outside Submission Unit, but within Application
- 2.2.4 Reference Information in Another Application
- 2.2.5 Referencing Information Owned by an External Party
- 2.2.6 Updating Information that Links to Other Information
- 2.2.7 Update a Referenced Document in a Previous Submission
- 2.2.8 Indirect Referencing
- 2.2.9 Reference Paper Information from Electronic Source
- 2.2.10 Reference External Electronic Source/Non-Retrievable
- 2.2.11 Reference Electronic Source/Retrievable
- 2.2.12 Referencing Approval Information
- 2.2.13 Provide Access/Permission to a Submission
- 2.2.14 Permit Use of Master File/Master Access
- 2.2.15 Comparison Information
- 2.3 Information about the Submission
- 2.1 Two-way Communication
