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1. What are the different document types that can be submitted through the CDER DIRECT portal?
62526 views
|79|
|DOCUMENT TYPESFORMS
The following document types are currently availab.. (Read more)

2. How many users can my Organization have?
58164 views
|38|
|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?
57742 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?
57549 views
|20|
|LOGIN
No. CDER DIRECT allows a person to login from only.. (Read more)

5. How can users be added to the Organization?
58359 views
|43|
|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?
57160 views
|24|
|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?
57309 views
|18|
|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?
57702 views
|63|
|FORMSUSERS
Once the user is logged in as an Administrator, un.. (Read more)

9. What is HL7?
56748 views
|14|
|STANDARDS
Health Level Seven International is one of several.. (Read more)

10. What is an SPL message?
57288 views
|22|
|SPL
The Structured Product Labeling (SPL) is a documen.. (Read more)

11. What is a Root ID in an SPL?
57877 views
|20|
|SPL
The Root ID uniquely identifies a specific Submiss.. (Read more)

12. What is a Set ID in an SPL?
60134 views
|20|
|SPL
The Set ID uniquely identifies a group of versions.. (Read more)

13. How do versions work in an SPL?
57047 views
|16|
|SPL
The version number gives sequential order to the d.. (Read more)

14. How do I transfer admin rights from one user to another?
57539 views
|18|
|ADMINISTRATIONUSERS
Only a user with administrator access can modify t.. (Read more)

15. How do I remove an admin from an organization’s account?
57661 views
|21|
|ADMINISTRATIONUSERS
Only a user with administrator access can remove a.. (Read more)

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What are the different document types that can be submitted through the CDER DIRECT portal?
62526 views
|79|
The following document types are currently available through CDER DIRECT at this time: o NDC Labeler Code Request • NDC Labeler Code Inactivation o Establishment Registration • No Change Notification • Out of Business Notification • Establishment De-Registration o Product Listing • Bulk Ingredient • Cellular Therapy • Human OTC Drug Label • Human Prescription Drug Label • Human Compounder Drug Label • Non-Standardized Allergenic Label • Plasma Derivative • Standardized Allergenic • Vaccine Label o Whole Sale Drug Distributors / Third Party Logistics • WHOLESALE DRUG DISTRIBUTORS AND THIRD-PARTY LOGISTICS FACILITY REPORT • Out Of Business Notification • Withdrawal of Wholesale Drug Distributors and Third-Party Logistics Provider Report