First there were paper submissions. Then there were several attempts to bring annual and routine submissions into the digital age with varying success and flaws.
Structured Product Labeling (SPL) is a standard document markup from Health Level Seven (HL7) that the FDA adopted in 2004 for submitting product and facility information such as Establishment Registration (submitted annually), Out of Business Notifications, NDC Labeler Code Requests, Drug Product Listing (submitted after approval and updated after changes). After the passage of Generic Drug User Fee Amendments of 2012 (GDUFA), Self-Identification was added to the list.
Previous Options/Resources:
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Manual
If you had a general grasp of XML, you could read the Implementation Guide with Validation Procedures guidance document and create the SPL in any XML editor program or any program that allowed you to Save As ‘.xml’. Even a program as simple as Notepad could technically create a XML file. Then upload through the Pragmatic Validator and if there are 0 errors, submit through Electronic Submission Gateway (ESG) or Gateway-to-Gateway AS2.
But why should you need to learn XML? Did I mention the latest Implementation Guide is 157-pages? Why??? The whole process could be as simple as filling out a form. For simpler submissions, this process could be as quick as signing up for a new gmail address, 2 minutes tops.
Validator
http://validator.pragmaticdata.com/validator-lite/validator/spl/
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XForms
XForms is a template offered through the GlobalSubmit website. The FDA released a guidance document with Step-by-Step Instructions with a few revisions. I tried this tool years ago and ran into a lot of lag when trying to use the Microsoft-Word-like text editing buttons when creating product listings. It was quicker to learn XML than to attempt to create a table with this method.
Guidance – Step-by-Step Instructions for Creating Structured Product Labeling (SPL) Files for Drug Establishment Registration and Drug Listing v2.0
http://www.fda.gov/forindustry/datastandards/structuredproductlabeling/default.htm
XForms
http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm189651.htm
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eSubmitter
eSubmitter was a stand-alone program downloaded on your computer. This worked better than XForms for me. Unfortunately, programs that run on your computer may cause you to run into a host of compatibility problems (conflicts with other programs, operating system upgrades, etc.). eSubmitter creates validated packages for a variety of centers and submissions but the use still needs to submit via CD or the gateway.
eSubmitter
http://www.fda.gov/forindustry/fdaesubmitter/default.htm
Hello CDER Direct!
The newest addition to the FDA’s SPL submission resources. The website possesses a clean, easy to navigate interface. Props to the U/I team for embracing whitespace and slowly updating the look of the organization’s webpages.
1. Create an account.
2. Fill out the form
3. Click submit.
The website validates and submits to CDER directly, as the name indicates. No need for an ESG account. Check back the next day and see if the submission was successful.
The website has just recently been rolled out, and current submission options include Drug Registration and Listing, GDUFA Self-Identification, and Human Compounded Drug Label.
CDER Direct
https://direct.fda.gov/
Questions
cderdirect@fda.hhs.gov
As the organization continues to transition to an electronic submission environment and provide new resources, I look forward to seeing more tools such as CDER Direct that simplify and allow for a more straightforward implementation of regulations.
regulatorydispatch 