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:

Contents

Introduction and General Topics

General Topics

Topic Example

Scenarios

Two-way Communication

Submission Activities

Meeting Requests and Responses

Follow-up/Post-market

Pre-submission Activities

Informal Interactions

Waiver Requests

Notification of Decision

Recalls

Withdraw from Market after Approval

Public Health Risk Notification

Labeling Negotiations: Request for Additional Information

Interagency Negotiations

Questions about where to find content (“I can’t find it”)

Questions from Sponsor to Agency and Resulting Response

Questions from Regulatory Authority and Sponsor Response

Identify Administrative Actions

Referencing

Reference Document within Submission Unit

Referencing Document between Submissions

Referencing outside Submission Unit, but within Application

Reference Information in Another Application

Referencing Information Owned by an External Party

Updating Information that Links to Other Information

Update a Referenced Document in a Previous Submission

Indirect Referencing

Reference Paper Information from Electronic Source

Reference External Electronic Source/Non-Retrievable

Reference Electronic Source/Retrievable

Referencing Approval Information

Provide Access/Permission to a Submission

Permit Use of Master File/Master Access

Comparison Information

Information about the Submission

Information about the Submission