CDER Direct

CDER Direct

 

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.

Establishment Registration

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.

 

Drug Listings

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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Marc is dedicated to helping his clients navigate the complex world of FDA and USDA legislation. He represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device, and drug industries.

Marc is the author of two textbooks and a lecturer at Northeastern University. He is a member of the Washington State Bar Association and the D.C. Bar Association.

7 Comments

  1. Adam Harris on August 28, 2018 at 1:37 pm

    When trying to add images in the labeling in the Content section, after I uploaded the image and try to insert the image, I keep getting the ‘undefined’ label instead of the image itself.

    • Marc Sanchez on August 28, 2018 at 3:20 pm

      Thank you for your comment. I often find the “undefined” label error is caused by a slow upload. Try saving the changes and see if the image loads in the main Content of Labeling page. If that doesn’t work, reduce the file size or try renaming the file.

    • shean strong on January 23, 2019 at 4:51 pm

      There are a couple of errors I found that would cause your issue. Strange symbols in the file name #$%^ will cause this problem as well as a file name that is too long. The size of the file but the system will tell you if that is the case.

  2. Tracey Barth on May 29, 2018 at 11:50 am

    HI Marc,

    So I just put in the part352 and it did get rid of the errors. However I am getting the following error message on the front/main page

    1 error has occurred
    Error in Product with Product NDC : 42508-205 (Go to error)

    Then when I open up the product, there are no error messages there.

    Your assistance is greatly appreciated.

    Tracey

    • Marc Sanchez on May 29, 2018 at 12:06 pm

      Tracey,

      Thank you for the follow-up. Without screenshots its hard to say what’s causing the error. I would recommend reaching out to CDER Direct support. You can also e-mail me if you’re interested in any of my drug listing services.

  3. Tracey Barth on May 22, 2018 at 9:20 am

    Do you have any advise on the following error messages for an OTC SPF product?

    3 errors have occurred
    If the code is C73603 (OTC monograph final) or C73604 (OTC monograph not final), then the id root must be 2.16.840.1.113883.3.149 (Code of Federal Regulations) (Go to error)
    If the code is C73603 (OTC monograph final), then all active ingredient codes (if any) must match an entry in the OTC validation-final-all list for that monograph citation (id extension). (Go to error)
    If the code is C73603 (OTC monograph final), then at least one active ingredient code (if any) must match an entry in the OTC validation-final list (see FDA SPL web page for list http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm) for that monograph citation (id extension). (Go to error)

    • Marc Sanchez on May 22, 2018 at 9:31 am

      Thank you for your message. Two of the errors are linked to the monograph citation and the active ingredients used. You likely have the field “Application Number/Regulatory Citation” filled incorrectly or are using active ingredients not found in the sunscreen monograph. The other error most likely would resolve once the other two are remedied.

      I offer a fixed (flat) fee for completing drug listings. You can e-mail me (msanchez@fdaatty.com) if you’re interested in learning more.

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