CDER NextGen Portal Frequently Asked Questions

What is the CDER NextGen Portal?

The CDER NextGen Portal was developed to improve submission processing and to foster interaction with developers of drug development tools. The Portal serves as a central location for submitting submissions, viewing submission statuses, and reviewing communications from the FDA. 

This is a common submission portal for all Drug Development Tool (DDT) electronic submissions with the exception of submissions to the ISTAND Pilot Program (see below); including those that are CDER-specific, CBER-specific, or applicable across both Centers. Please note, there are no fees associated with the DDT Qualification Program. 

Can I still send Drug Development Tool submissions by mail or e-mail? 

No. All DDT qualification program submissions are transmitted through the CDER NextGen Portal, with the exception of submissions to the ISTAND Pilot Program.

Can I submit ISTAND submissions through the CDER NextGen Portal?

No. Requestors should transmit ISTAND submissions via email to ISTAND@fda.hhs.gov. Additional information about the ISTAND Pilot Program submission process is available on the ISTAND webpage.

Can I submit CBER-specific DDT submissions through the CDER NextGen Portal?

Yes. Requestors should transmit CBER-specific DDT submissions through the CDER NextGen Portal.

Can I transmit a single submission with multiple DDT development proposals through the CDER NextGen Portal?

No. Requestors must submit DDT proposals separately even if they are related. A single Context of Use (COU) should be articulated for a given DDT qualification submission and DDT development effort even though the long-term goal may include multiple COUs.

How do I get access to the CDER NextGen Portal? 

The first step to sending a submission to any of the DDT Qualification Programs, with the exception of submissions to the ISTAND Pilot Program, is to create an account in the CDER NextGen Portal. Each organization can add a primary Requestor to serve as account manager for the Portal. In addition to the primary Requestor, each organization can add an Alternate Contact or Partner Organization to receive email notifications regarding the status of the DDT qualification submission. To create an account in the CDER NextGen Portal, please refer to this reference guide or this video for instructions on the enrollment process.  

How do I identify my organization in the CDER NextGen Portal? 

The Portal will attempt to import your organization’s DUNS number automatically by performing a search in the Organization Information section. In some cases, the DUNS number will have to be entered manually. Please have this information available at the time of registration. 

If your organization does not have a DUNS number, you can manually enter in ‘999999999’ as the DUNS number. 

How do I register an Alternate Contact or Partner Organization in the CDER NextGen Portal? 

The CDER NexGen Portal allows you to register an Alternate Contact or Partner Organization (i.e., consortium, workgroups, etc.) to your DDT program.  

Alternate Contacts are individuals within your organization that will receive email notifications regarding updates to the DDT submission status. 

Partner Organizations (i.e., workgroups, consortia, etc.) are affiliated organizations working with the Organization on a DDT Qualification Program submission. 

Please refer the step-by-step instructions on page 15 to enter Partner Organization and Alternate Contacts. 

Do Partner Organizations or Alternate Contacts have access to the DDT submissions? 

No. Partner Organizations will receive an automated email notification from the Portal when there is a change in the status of their DDT submission. However, Partner Organizations will not have access to FDA communications or DDT submission documents. The primary Requestor is responsible for distributing copies of FDA communications or DDT submission documents to the Partner Organizations. 

Alternate Contacts also receive automated  email notifications from the Portal regarding FDA communications and DDT submission status. The Alternate Contacts do not have access to Portal documents. The primary Requestor is responsible for distributing copies of FDA communications or DDT submission documents to the Alternate Contacts. 

If the Point of Contact changes for a DDT, the primary Requestor should contact the appropriate DDT Qualification Program: 

• Animal Model Qualification Program: CDERAnimalModelQualification@fda.hhs.gov  
• Biomarker Qualification Program: CDER-BiomarkerQualificationProgram@fda.hhs.gov 
• Clinical Outcome Assessment: COADDTQualification@fda.hhs.gov
• CEBER DDT Qualification program: CBER-DDTQualificationProgram@fda.hhs.gov
• ISTAND Pilot Program: ISTAND@fda.hhs.gov

How do I request transfer of ownership of a DDT submission to a different organization?

To transfer ownership of a DDT submission to a different organization, the primary Requestor should contact the appropriate DDT Qualification Program: 

• Animal Model Qualification Program: CDERAnimalModelQualification@fda.hhs.gov  
• Biomarker Qualification Program: CDER-BiomarkerQualificationProgram@fda.hhs.gov 
• Clinical Outcome Assessment: COADDTQualification@fda.hhs.gov
• CEBER DDT Qualification program: CBER-DDTQualificationProgram@fda.hhs.gov
• ISTAND Pilot Program: ISTAND@fda.hhs.gov

What browsers are supported by the CDER NextGen Portal?

The CDER NextGen Portal currently works best with the following browsers

• Firefox version 45 and above
• Google Chrome version 58 and above

How to submit a Drug Development Tool qualification submission? 

A complete reference guide on how to submit a DDT qualification submissions through the CDER NextGen Portal is available here. Find more information about specific DDT qualification submission stages on the following pages: 

• Submitting a Letter of Support (Biomarker Qualification Program Only) - CDER NextGen Portal Reference Guide, page 5
• Submitting a Letter of Intent - CDER NextGen Portal Reference Guide, page 12  
• Submitting a Pre-Qualification Plan (Pre-QP) Meeting Request or Qualification Plan (QP) - CDER NextGen Portal Reference Guide, page 19
• Submitting a Pre-Full Qualification Plan (Pre-FQP) Meeting Request or Full Qualification Plan (FQP) - CDER NextGen Portal Reference Guide, page 22
• Submitting an Amendment - CDER NextGen Portal Reference Guide, page 25
• Submitting a Meeting Request - CDER NextGen Portal Reference Guide, page 27
• Submitting Presentation Materials - CDER NextGen Portal Reference Guide, page 29
• Submitting an Information Request Response - CDER NextGen Portal Reference Guide, page 31
• Submitting a Withdrawal - CDER NextGen Portal Reference Guide, page 33

How can I view notifications in the CDER NextGen Portal? 

For step-by-step instructions on page 35 of the CDER NextGen Portal Reference Guide to learn how to access the Activity Log and Notifications in the CDER NextGen Portal.

How do I get additional information about the CDER NextGen Portal? 

For general questions about the CDER NextGen Portal, please contact the appropriate DDT Qualification Program: 

• Animal Model Qualification Program: CDERAnimalModelQualification@fda.hhs.gov  
• Biomarker Qualification Program: CDER-BiomarkerQualificationProgram@fda.hhs.gov 
• Clinical Outcome Assessment: COADDTQualification@fda.hhs.gov 
• CEBER DDT Qualification program: CBER-DDTQualificationProgram@fda.hhs.gov
• ISTAND Pilot Program: ISTAND@fda.hhs.gov

For technical difficulties or issues accessing the CDER NextGen Portal please contact EDMSupport@fda.hhs.gov or refer to the CDER NextGen Portal Reference Guide.