CDER Direct is one of two tools commonly used for drug establishment registration, National Drug Code (NDC) relabeler code request, and drug listings. It is intended as an improvement on the Electronic Submissions Gateway (ESG) portal that relies on a SPL X-form editor. The integration of the SPL-X editor into the system is one of its helpful features. No longer do you need to create the submission in an editor, validate there are no errors and submit using the ESG. That integration, however, doesn’t mean the errors of the old system are gone. A mistake that would cause an error in an SPL-X editor will do the same in CDER Direct. The error messages are more visible in the bold red box at the top of the system but the underlying issues are the same. Below are some tips to help unravel some of the more common errors clients have come to us with.
The most common mistake made when register a new company as a drug establishment is the address on file with Duns and Bradsheet. CDER Direct will validate the address registered against the address on file with D&B based on the DUNS number entered. If the two don’t match, then you’ll need to update the address on file with D&B before resubmitting. This is less of an issue for new companies or companies that recently obtained a DUNS number. Still, the address must be exactly the same in both the establishment registration and D&B listing.
NDC Relabeler Request
Two mistakes are common when filing for NDC relabeler code both occur after the submission is filed. First, it is incredibly common to request a relabeler code well before any drug listings are submitted. CDER Direct explicitly warns users before completing a NDC relabeler request that the relabeler code issued will expire if not used. The relabeler code can be reactivated but if you don’t realize it expired that may be the source of an error in a drug listing. Second, is a failure to re-enter and re-submit the NFC relabeler code into the request. This is a way to validate or activate the assigned relabeler code. A similar step is necessary for the establishment registration when the FEI is assigned.
There are dozens of drug listing errors that would take a whole book to cover. Below is a list of a few.
- Missing required sections of the Content of Labelling;
- Pasting formatted text into Content of Labeling;
- Error with PDP image;
- Wrong regulatory citation; or
- Using the wrong denominator when adding an active ingredient.
Contact our Washington D.C. or Research Triangle offices with any questions.
**Disclaimer: Marc C. Sanchez, Esq. is a FDA attorney in private practice and the above is not intended as legal advice. FDA Atty law firm is hosting this blog solely for educational purposes.**
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