Advice from the FDA, Part 1: Technical Errors to Avoid in Your eCTD Submissions
One of the best reasons to attend industry conferences is to hear the speakers from the FDA. Over the past year, Agency staffers have presented at seven different conferences focused on electronic submissions. Because these conferences are always a treasure trove of great information and advice, it’s hard to pass up an opportunity to hear about eCTD best practices straight from the horse’s mouth.
I sat down this week to review some of these presentations while preparing for an upcoming training session, and I realized that it would be great to share this information with a wider audience. Today, I’ll focus on five of the most common technical errors cited by the FDA speakers and how you can avoid them (Part 1). Next time, I’ll focus on some of the advice offered on how you can make life easier for the FDA reviewers (Part 2).
Always Send Module 1 with Any eCTD Submission
I would never have guessed that this was an issue, but CDER’s Ginny Ventura devoted one full slide to discussing this at the 2009 DIA EDM conference. Even if your submission is a CMC update composed entirely of documents in Module 3, you still must include a cover letter and FDA form (1571 or 356h, as appropriate) in Module 1. Module 1 identifies your application and sequence in the FDA’s automated systems, and a cover letter can help reviewers identify any atypical information in the submission.
Check Your Numbers
Your application number should always be six digits and your sequence number should always be four digits. You should ensure that you use the same application and sequence number on all documents throughout your submission. Also, you should confirm that you are submitting the correct form for your application (e.g. don’t submit a Form FDA 1571 with a NDA submission).
Don’t Submit “Extra” Files
The FDA continues to receive submission that include folders and files that have not been included as part of the eCTD’s XML. If files are not referenced within the eCTD, they are not visible within the reviewing software and the reviewers will never see them.
Don’t Use “Bad” Characters in File or Folder Names
While the use of spaces in file names has been allowed by Windows for about 15 years, it is still not acceptable to use spaces in file or folder names in an eCTD submission. Consider using a hyphen or underscore instead. Other characters that are not allowed include:
/ - forward slash
\ - backslash
: - colon
? - question mark
“ - quotation marks
< - less than sign
> - greater than sign
| - vertical bar
Learn to Use the Electronic Submissions Gateway (ESG)
When uploading a submission through the ESG, it is vital that you select the correct options so that your submission is routed correctly. Check to make sure that you’ve selected the correct center (CDER vs. CBER). Also, make sure that for submission type, you select eCTD, and not eNDA or eIND.
Any one of these errors will result in a rejection of your submission. Fortunately, good eCTD publishing software can help you avoid most of these errors “behind the scenes,” and the rest of them can be avoided with good quality control processes and the help of an experienced regulatory submissions specialist.
Stay tuned for Part 2, where I’ll discuss the ways that you can keep your FDA reviewers happy and make their jobs a little easier.
Evan is the Director of Regulatory Operations for Cato Research (www.cato.com), where he leads a team of specialists that produces over 300 regulatory submissions each year. Evan specializes in eCTD submissions and has additional experience in FDA interactions, biologic products, technology transfers, and post-marketing activities. Evan is also a regular contributor at www.ask-cato.com. Evan can be contacted on LinkedIn (www.linkedin.com/in/evanrichardson) or via email at firstname.lastname@example.org.