What is NextGen Portal?

The NextGen Collaboration Portal was developed as part of an initiative to improve submission processing and to foster interaction with Industry. 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 Tools electronic submissions; 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 (DDT) submissions by mail or email?

No. After July 17, 2019, all biomarker qualification program submissions will be transmitted through the NextGen Collaboration Portal.

How to Get Access to Portal?

The first step to sending a submission to the Biomarker Qualification Program is to create an account in the NextGen Collaboration Portal. Each organization can add up to two new users to serve as account managers for Portal. To create an account in the NextGen Collaboration Portal please refer to the following step-by-step guide for enrollment instructions.

How do I identify my organization in NextGen Collaboration Portal?

Portal will attempt to import your organization’s DUNS number automatically by performing a search in the Organization Information section. In some cases, DUNS number will have to be entered manually. So, 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 their DUNS.

How do I register Alternate Contacts and Partner Organizations (i.e. workgroups, consortia, etc.) in Portal?

CDER NexGen Portal allows you to register Alternate Contacts and Partner Organizations (i.e. consortium, workgroups, etc.) to your DDT program. Alternate Contacts are individuals within your organization that will receive email notifications regarding updates regarding the DDT submission status.

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

Please refer the step-by-step instructions to enter partner organization and alternate contacts.

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

Partner Organizations will receive a separate email notification when the status changes for a DDT submission. Partner organizations will not have access to FDA communications or submission documents, and they must contact the primary Requestor to receive access to Portal documents.

Alternate Contacts also receives emails regarding FDA communications and submission status. The Alternate Contact do not have access to Portal documents. The Alternate Contact must go through the primary Requestor to view submission documents or communications from FDA.

If the Point of Contact changes for a DDT, the primary Requestor should contact [email protected].

What browsers are supported by NextGen Collaboration Portal?

CDER NextGen Portal currently works best with the following browsers

• Firefox version 45 and above
• Internet Explorer version 11 and above
• Google Chrome version 58 and above

How to a submit a Letter of Intent (LOI) or Letter of Support (LOS) submission to the Portal?

Please refer to the step-by-step instructions and video to help you with the process of submitting a LOI or LOS submission:

How to submit a new QP or FQP to the NextGen Collaboration Portal?

Please refer to the step-by-step instructions and video for submitting a QP or FQP submission to the Biomarker Qualification Program:

How to submit an Amendment or Withdrawal for an existing DDT project in Portal?

Please refer to the step-by-step instructions and video for submitting an Amendment or Withdrawal Request submission:

How do I get additional information about NextGen Portal?

For general questions about the NextGen Portal, please contact the Biomarker Qualification Program at [email protected]

For technical difficulties or issues accessing NextGen Portal please contact [email protected] or refer to the CDER NextGen Portal FAQs.