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1. What are the different document types that can be submitted through the CDER DIRECT portal?
833 views
|20|
|DOCUMENT TYPESFORMS
"The following document types are currently availa.. (Read more)

2. How many users can my Organization have?
590 views
|12|
|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?
286 views
|6|
|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?
383 views
|5|
|LOGIN
No. CDER DIRECT allows a person to login from only.. (Read more)

5. How can users be added to the Organization?
304 views
|4|
|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?
369 views
|9|
|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?
252 views
|5|
|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?
391 views
|27|
|FORMSUSERS
Once the user is logged in as an Administrator, un.. (Read more)

9. What is HL7?
418 views
|2|
|STANDARDS
Health Level Seven International is one of several.. (Read more)

10. What is an SPL message?
309 views
|6|
|SPL
The Structured Product Labeling (SPL) is a documen.. (Read more)

11. What is a Root ID in an SPL?
356 views
|7|
|SPL
The Root ID uniquely identifies a specific Submiss.. (Read more)

12. What is a Set ID in an SPL?
359 views
|1|
|SPL
The Set ID uniquely identifies a group of versions.. (Read more)

13. How do versions work in an SPL?
444 views
|7|
|SPL
The version number gives sequential order to the d.. (Read more)

14. How do I transfer admin rights from one user to another?
321 views
|3|
|ADMINISTRATIONUSERS
Only a user with administrator access can modify t.. (Read more)

15. How do I remove an admin from an organization’s account?
458 views
|4|
|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?
833 views
|20|
"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 "