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1. What are the different document types that can be submitted through the CDER DIRECT portal?
62061 views
|37|
|DOCUMENT TYPESFORMS
The following document types are currently availab.. (Read more)

2. How many users can my Organization have?
57985 views
|25|
|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?
57614 views
|22|
|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?
57406 views
|17|
|LOGIN
No. CDER DIRECT allows a person to login from only.. (Read more)

5. How can users be added to the Organization?
58008 views
|15|
|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?
57080 views
|16|
|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?
57207 views
|15|
|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?
57589 views
|38|
|FORMSUSERS
Once the user is logged in as an Administrator, un.. (Read more)

9. What is HL7?
56708 views
|12|
|STANDARDS
Health Level Seven International is one of several.. (Read more)

10. What is an SPL message?
57204 views
|20|
|SPL
The Structured Product Labeling (SPL) is a documen.. (Read more)

11. What is a Root ID in an SPL?
57812 views
|19|
|SPL
The Root ID uniquely identifies a specific Submiss.. (Read more)

12. What is a Set ID in an SPL?
59939 views
|18|
|SPL
The Set ID uniquely identifies a group of versions.. (Read more)

13. How do versions work in an SPL?
56999 views
|14|
|SPL
The version number gives sequential order to the d.. (Read more)

14. How do I transfer admin rights from one user to another?
57437 views
|14|
|ADMINISTRATIONUSERS
Only a user with administrator access can modify t.. (Read more)

15. How do I remove an admin from an organization’s account?
57528 views
|15|
|ADMINISTRATIONUSERS
Only a user with administrator access can remove a.. (Read more)

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What is an SPL message?
57204 views
|20|
The Structured Product Labeling (SPL) is a document markup standard approved by Health Level Seven (HL7) and adopted by FDA as a mechanism for exchanging product and facility information.