The FDA is moving forward with digitalisation in all areas and the CDER NextGen Portal is a good example.

What is the CDER NextGen portal?

CDER’s NextGen Portal is a cloud based system for users to report information to the FDA. From Drug Development Tools (DDTs) to amendment submissions, stakeholders can utilise the NextGen Portal. This collaboration platform continues to reduce regulatory overheads for sponsors, research institutes and small businesses alike.

Submissions that can utilise the NextGen Portal include:

  • Letter of Intent (LOI) submissions: The LOI is the first DDT Stage submission for the FDA to review to determine whether the DDT will be accepted into the DDT Qualification Program.
  • Qualification Plan (QP) submissions: The QP is the second DDT Stage submission for the FDA to review. A QP submission can be submitted only after the DDT has received an “Accepted” LOI.
  • Full Qualification Package (FQP) submissions: The FQP is the third DDT Stage submission for the FDA to review. An FQP submission can be submitted only after the DDT has received an “Accepted” QP.

Additional submission types worth mentioning are non-eCTD submissions for applications that have been granted an eCTD waiver as well as research INDs.

How does it work?

The NextGen Portal offers real-time interactions between sponsor and regulator. Having submitted the initial research IND, the FDA sends an acknowledgement letter back to the sponsor directly via the portal. After the initial IND review, further information requests might be sent by the FDA, again via the portal. Sponsors can then use the portal to respond to any information request and submit amendments and/or clinical study data.

What are the benefits of submitting via the CDER NextGen Portal?

  • Efficiency: Eliminate the time and hassle of printing and mailing paper or physical media via online submission.
  • Timeliness: No more waiting for submission delivery, electronic delivery is instantaneous.
  • Ease of Use: Requesting via the Portal is easy, and all information regarding any request is stored in one place.
  • Automated confirmation: Receive automated confirmation of all transactions.

In summary

Another step into the right direction, simplifying the submission process and communication between regulator and sponsor. With technology around digitalisation in the pharmaceutical industry constantly evolving, the CDER NextGen Portal is certainly a step in the right direction.

Published by Olaf Schoepke

Passionate about sharing ideas with regulatory professionals in the human and veterinary medicinal product space.

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