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U.S. Food and Drug Administration
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  3. Drug Safety and Availability
  4. Drug Supply Chain Integrity
  5. Drug Supply Chain Security Act (DSCSA)
  6. Drug Supply Chain Security Act (DSCSA) Portal in CDER NextGen
  1. Drug Supply Chain Security Act (DSCSA)

Drug Supply Chain Security Act (DSCSA) Portal in CDER NextGen

DSCSA Portal in CDER NextGen

CDER NextGen includes a Drug Supply Chain Security Act (DSCSA) portal that enables FDA and trading partners to communicate when FDA requests information related to investigations of suspect or illegitimate products or during a recall. 

The DSCSA portal is used to:  

  • Confirm basic information and points of contact for trading partners
  • Notify trading partners when they have messages from FDA
  • Enable trading partners to respond to FDA messages and upload documents

The DSCSA portal provides a simple website for trading partners to submit information to FDA.

FDA asks 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 DSCSA portal. Trading partners will then use the DSCSA portal to respond to FDA requests, including uploading documents.

Document Formats Used to Submit Information through the DSCSA Portal

Information can be uploaded into the DSCSA portal in the following formats:

  • DOC or DOCX (Microsoft Word)
  • JSON (JavaScript Object Notation)
  • PDF (Portable Document Format)
  • XLS or XLSX (Microsoft Excel)
  • XML (Extensible Markup Language)

Resources on How to Use the DSCSA Portal

The DSCSA portal reference guide provides a step-by-step guide to submit DCSCA information through CDER NextGen. Additional information, including an FAQ guide and video tutorials, are available in the CDER NextGen Help Center within the DSCSA portal after signing in.

Contact

 

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