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1. What are the different document types that can be submitted through the CDER DIRECT portal?
62504 views
|76|
|DOCUMENT TYPESFORMS
The following document types are currently availab.. (Read more)

2. How many users can my Organization have?
58157 views
|35|
|ADMINISTRATIONUSERS
There is no limit on how many users an Organizatio.. (Read more)

3. Can I have more than one user from my organization use the portal to submit SPLs?
57737 views
|31|
|USERS
There is no limit on how many users an Organizatio.. (Read more)

4. Can more than one person use a single login at the same time?
57535 views
|19|
|LOGIN
No. CDER DIRECT allows a person to login from only.. (Read more)

5. How can users be added to the Organization?
58348 views
|42|
|ADMINISTRATIONUSERS
Once a user has created an account with CDER DIREC.. (Read more)

6. What is the role of a general user in CDER DIRECT within the organization?
57159 views
|23|
|ADMINISTRATIONUSERS
A general user will have access to the forms/docum.. (Read more)

7. What is the role of an administrator in CDER DIRECT within the organization?
57305 views
|17|
|ADMINISTRATION
An organization Administrator has the ability to .. (Read more)

8. When I created my account with CDER DIRECT for my organization, I did not give myself access to the forms that I need. How can I give my organization access?
57692 views
|62|
|FORMSUSERS
Once the user is logged in as an Administrator, un.. (Read more)

9. What is HL7?
56745 views
|13|
|STANDARDS
Health Level Seven International is one of several.. (Read more)

10. What is an SPL message?
57280 views
|22|
|SPL
The Structured Product Labeling (SPL) is a documen.. (Read more)

11. What is a Root ID in an SPL?
57869 views
|19|
|SPL
The Root ID uniquely identifies a specific Submiss.. (Read more)

12. What is a Set ID in an SPL?
60114 views
|20|
|SPL
The Set ID uniquely identifies a group of versions.. (Read more)

13. How do versions work in an SPL?
57045 views
|15|
|SPL
The version number gives sequential order to the d.. (Read more)

14. How do I transfer admin rights from one user to another?
57533 views
|17|
|ADMINISTRATIONUSERS
Only a user with administrator access can modify t.. (Read more)

15. How do I remove an admin from an organization’s account?
57650 views
|19|
|ADMINISTRATIONUSERS
Only a user with administrator access can remove a.. (Read more)

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How do versions work in an SPL?
57045 views
|15|
The version number gives sequential order to the different versions of an SPL submission. The version number is a whole number greater than zero, such as 6, 7, or 8. The version number is increased with each change to the SPL submission.