The FDA’s CDER NextGen Portal (CDER NextGen) now includes a Drug Supply Chain Security Act (DSCSA) portal that enables the FDA and trading partners to communicate when the FDA requests information related to investigations of suspect or illegitimate products or during a recall.
The DSCA portal is used to:
- Confirm basic information and points of contact for trading partners
- Notify trading partners when they have messages from the FDA
- Enable trading partners to respond to FDA messages and upload documents
Where is the DSCSA portal?
Access the DSCSA portal through CDER NextGen.
Does the DSCSA portal require specialized software or hardware?
No. The DSCSA portal does not require specialized software or hardware, although users must register for an account.
Is the DSCSA portal able to access a trading partner’s individual systems and data?
No. A trading partner’s information cannot be accessed by the FDA through this portal. Trading partners use the portal to respond to FDA requests for information, including uploading documents.
When will the FDA ask a trading partner to use the DSCSA portal?
The FDA will ask a trading partner to use the DSCSA portal when the agency is investigating suspect or illegitimate products or during a recall. Trading partners will be notified via email when they have a message in the portal.
Which file formats can be uploaded into the DSCSA portal?
- DOC or DOCX (Microsoft Word)
- PDF (Portable Document Format)
- XLS or XLSX (Microsoft Excel)
- XML (Extensible Markup Language)
Which resources are available to help trading partners learn how to use the DSCSA portal?
See the following guides and video tutorials for additional information about using the DSCSA portal:
- FAQs for FDA's DSCSA portal: Common questions and answers about the DSCSA submission process
- FDA's DSCSA portal reference guide: Step-by-step guide for submitting DCSCA information in the CDER NextGen DSCSA portal
- Video Tutorials: Step-by-step video tutorials for submitting DSCSA information through the CDER NextGen DSCSA portal (accessible after signing in)
- Trading partner confirmation in the CDER NextGen DSCSA portal
- Initial submission in the CDER NextGen DSCSA portal
- Submitting responses to FDA information requests in the CDER NextGen DSCSA portal