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(New page: This page consolidates the information drafted and discussed during the business scenario development sessions at the July 24, 2008, Requirements Kick-off meeting in Silver Spring, Marylan...) |
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* [[Information about the Submission]] | * [[Information about the Submission]] | ||
− | + | =Two-way Communication= | |
− | =1. Submission Activities= | + | ==1. Submission Activities== |
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|} | |} | ||
− | =2. Meeting Requests and Responses= | + | ==2. Meeting Requests and Responses== |
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|} | |} | ||
− | =3. Follow-up/Post-market= | + | ==3. Follow-up/Post-market== |
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|} | |} | ||
− | =4. Pre-submission Activities= | + | ==4. Pre-submission Activities== |
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− | =5. Informal Interactions= | + | ==5. Informal Interactions== |
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|} | |} | ||
− | =6. Waiver Requests= | + | ==6. Waiver Requests== |
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− | =7. Notification of Decision= | + | ==7. Notification of Decision== |
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− | =8. Recalls= | + | ==8. Recalls== |
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− | =9. Withdraw from Market after Approval= | + | ==9. Withdraw from Market after Approval== |
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|} | |} | ||
− | =10. Public Health Risk Notification= | + | ==10. Public Health Risk Notification== |
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|} | |} | ||
− | =11. Labeling Negotiations: Request for Additional Information= | + | ==11. Labeling Negotiations: Request for Additional Information== |
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|} | |} | ||
− | =12. Interagency Negotiations= | + | ==12. Interagency Negotiations== |
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|} | |} | ||
− | =13. Questions about where to find content (“I can’t find it”)= | + | ==13. Questions about where to find content (“I can’t find it”)== |
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|} | |} | ||
− | =14. Questions from Sponsor to Agency and Resulting Response= | + | ==14. Questions from Sponsor to Agency and Resulting Response== |
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|} | |} | ||
− | =15. Questions from Regulatory Authority and Sponsor Response= | + | ==15. Questions from Regulatory Authority and Sponsor Response== |
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|} | |} | ||
− | Referencing | + | =Referencing= |
− | =16. Reference Document within Submission Unit = | + | ==16. Reference Document within Submission Unit== |
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|} | |} | ||
− | =17. Referencing document between submissions= | + | ==17. Referencing document between submissions== |
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|} | |} | ||
− | =18. Referencing outside submission unit, but within application= | + | ==18. Referencing outside submission unit, but within application== |
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|} | |} | ||
− | =19. Reference Information in another Application= | + | ==19. Reference Information in another Application== |
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|} | |} | ||
− | =20. Referencing Information owned by an External Party= | + | ==20. Referencing Information owned by an External Party== |
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|} | |} | ||
− | =21. Updating Information that links to other information= | + | ==21. Updating Information that links to other information== |
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| | | | ||
|} | |} | ||
− | =22. Update a Referenced Document in a Previous Submission= | + | |
+ | ==22. Update a Referenced Document in a Previous Submission== | ||
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|} | |} | ||
− | =23. Indirect Referencing= | + | ==23. Indirect Referencing== |
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|} | |} | ||
− | =24. Reference Paper Information from Electronic Source= | + | ==24. Reference Paper Information from Electronic Source== |
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|} | |} | ||
− | =25. Reference External Electronic Source/Non-Retrievable= | + | ==25. Reference External Electronic Source/Non-Retrievable== |
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|} | |} | ||
− | =26. Reference Electronic Source/Retrievable= | + | ==26. Reference Electronic Source/Retrievable== |
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|} | |} | ||
− | =27. Referencing Approval Information= | + | ==27. Referencing Approval Information== |
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|} | |} | ||
− | =28. Provide Access/Permission to a Submission= | + | ==28. Provide Access/Permission to a Submission== |
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|} | |} | ||
− | =29. Permit Use of Master File/Master Access= | + | ==29. Permit Use of Master File/Master Access== |
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|} | |} | ||
− | =30. Comparison Information= | + | ==30. Comparison Information== |
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|} | |} | ||
− | Information about the Submission | + | =Information about the Submission= |
− | =31. Information about the Submission= | + | ==31. Information about the Submission== |
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|} | |} | ||
− | =32. Identify Administrative Actions= | + | ==32. Identify Administrative Actions== |
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|-valign="top" | |-valign="top" |
Revision as of 18:12, 14 August 2008
This page consolidates the information drafted and discussed during the business scenario development sessions at the July 24, 2008, Requirements Kick-off meeting in Silver Spring, Maryland. The business
scenarios have three categories, corresponsing to the three scoping statements:
Contents
- 1 Two-way Communication
- 1.1 1. Submission Activities
- 1.2 2. Meeting Requests and Responses
- 1.3 3. Follow-up/Post-market
- 1.4 4. Pre-submission Activities
- 1.5 5. Informal Interactions
- 1.6 6. Waiver Requests
- 1.7 7. Notification of Decision
- 1.8 8. Recalls
- 1.9 9. Withdraw from Market after Approval
- 1.10 10. Public Health Risk Notification
- 1.11 11. Labeling Negotiations: Request for Additional Information
- 1.12 12. Interagency Negotiations
- 1.13 13. Questions about where to find content (“I can’t find it”)
- 1.14 14. Questions from Sponsor to Agency and Resulting Response
- 1.15 15. Questions from Regulatory Authority and Sponsor Response
- 2 Referencing
- 2.1 16. Reference Document within Submission Unit
- 2.2 17. Referencing document between submissions
- 2.3 18. Referencing outside submission unit, but within application
- 2.4 19. Reference Information in another Application
- 2.5 20. Referencing Information owned by an External Party
- 2.6 21. Updating Information that links to other information
- 2.7 22. Update a Referenced Document in a Previous Submission
- 2.8 23. Indirect Referencing
- 2.9 24. Reference Paper Information from Electronic Source
- 2.10 25. Reference External Electronic Source/Non-Retrievable
- 2.11 26. Reference Electronic Source/Retrievable
- 2.12 27. Referencing Approval Information
- 2.13 28. Provide Access/Permission to a Submission
- 2.14 29. Permit Use of Master File/Master Access
- 2.15 30. Comparison Information
- 3 Information about the Submission
Two-way Communication
1. Submission Activities
Actors |
| |
Description | Request for Submission Number (with the idea that this may be done in an automated pre-submission manner). | |
Additional Information | Review Guidance Documents from each Authority (Note: May be difficult for EU) | |
Issues and Questions |
|
2. Meeting Requests and Responses
Actors |
| |
Description |
|
|
Additional Information | - | |
Issues and Questions |
decisions or it may define some aspects of the upcoming study agreed upon? |
3. Follow-up/Post-market
Actors |
| |
Description |
|
|
Additional Information | - | |
Issues and Questions |
|
4. Pre-submission Activities
Actors |
| |
Description |
|
|
Additional Information | - | |
Issues and Questions | The group indicated that "presubmission" requires definition. |
5. Informal Interactions
Actors |
| |
Description |
|
|
Additional Information | Refer to FDA/CDRH Guidance for Interactive Review | |
Issues and Questions |
you use the reply function. May be a request or an option should be foreseen.
|
6. Waiver Requests
Actors |
| |
Description |
|
|
Additional Information | - | |
Issues and Questions | This scenario needs examples of waivers |
7. Notification of Decision
Actors |
| |
Description |
|
|
Additional Information | - | |
Issues and Questions | Are there any other status options? |
8. Recalls
Actors |
| |
Description | Health Authority contacts sponsor of required recall | |
Additional Information |
|
|
Issues and Questions | - |
9. Withdraw from Market after Approval
Actors |
| |
Description |
|
|
Additional Information |
|
|
Issues and Questions | - |
10. Public Health Risk Notification
Actors |
| |
Description |
|
|
Additional Information |
|
|
Issues and Questions | DEFINE ACRONYM: Does BoH mean Board of Health |
11. Labeling Negotiations: Request for Additional Information
Actors |
| |
Description |
|
|
Additional Information | - | |
Issues and Questions |
|
12. Interagency Negotiations
Actors |
| |
Description |
|
|
Additional Information | - | |
Issues and Questions | Can the two agencies exchange questions once the negotiation is initiated? |
13. Questions about where to find content (“I can’t find it”)
Actors |
| |
Description |
|
|
Additional Information | This communication is accepted by e-mail, phone, fax, or formal letter. | |
Issues and Questions | Is this an informal interaction? Once the information was not located within previously submitted documentation, is that when it becomes formal? |
14. Questions from Sponsor to Agency and Resulting Response
Actors |
| |
Description |
|
|
Additional Information | This communication is accepted by e-mail, phone, or formal letter | |
Issues and Questions |
15. Questions from Regulatory Authority and Sponsor Response
Actors |
| |
Description |
(amendments on the closed parts) and a Member State (composition of the referenced product).
|
|
Additional Information | - | |
Issues and Questions | - |
Referencing
16. Reference Document within Submission Unit
Actors |
| |
Description | ||
Additional Information | ||
Issues and Questions |
17. Referencing document between submissions
Actors |
| |
Description | ||
Additional Information | ||
Issues and Questions |
18. Referencing outside submission unit, but within application
Actors |
| |
Description | ||
Additional Information | ||
Issues and Questions |
19. Reference Information in another Application
Actors |
| |
Description | ||
Additional Information | ||
Issues and Questions |
20. Referencing Information owned by an External Party
Actors |
| |
Description | ||
Additional Information | ||
Issues and Questions |
21. Updating Information that links to other information
Actors |
| |
Description | ||
Additional Information | ||
Issues and Questions |
22. Update a Referenced Document in a Previous Submission
Actors |
| |
Description | ||
Additional Information | ||
Issues and Questions |
23. Indirect Referencing
Actors |
| |
Description | ||
Additional Information | ||
Issues and Questions |
24. Reference Paper Information from Electronic Source
Actors |
| |
Description | ||
Additional Information | ||
Issues and Questions |
25. Reference External Electronic Source/Non-Retrievable
Actors |
| |
Description | ||
Additional Information | ||
Issues and Questions |
26. Reference Electronic Source/Retrievable
Actors |
| |
Description | ||
Additional Information | ||
Issues and Questions |
27. Referencing Approval Information
Actors |
| |
Description | ||
Additional Information | ||
Issues and Questions |
28. Provide Access/Permission to a Submission
Actors |
| |
Description | ||
Additional Information | ||
Issues and Questions |
29. Permit Use of Master File/Master Access
Actors |
| |
Description | ||
Additional Information | ||
Issues and Questions |
30. Comparison Information
Actors |
| |
Description | ||
Additional Information | ||
Issues and Questions |
Information about the Submission
31. Information about the Submission
Actors |
| |
Description | ||
Additional Information | ||
Issues and Questions |
32. Identify Administrative Actions
Actors |
| |
Description | ||
Additional Information | ||
Issues and Questions |