The Death of Paper – FDA eCopy

The Death of Paper – FDA eCopy

March 24th, 2013 // 2:39 am @

March 24, 2013

The date Dec. 30, 2012 was a big one for regulatory. This was the last day that you could submit a major application just on paper. In its place is the new eCopy system just finalized by FDA in January.

According to what we have been hearing from industry, many people are really struggling to understand the new guidance for eCopy. We have actually seen ourselves two applications that got an eCopy hold for murky reasons. We imagine that the document control center at the agency is pretty crazy these days!

Of course, eCopy is a new program and it is not unreasonable for there to be some kinks and issues to work out early on. But we do think it the long run, the eCopy system will be a big step ahead of the old fashioned paper system. FDA just needs to continue to streamline the eCopy process.

Avoid the eCopy Confusion!

Here are some basic observations we have made about eCopy to date:

  • If you have a submission going to the document control center, you probably want an eCopy. There are several submission types that do not to be an eCopy. But we think you may want to err on the side of caution here and submit an eCopy anyway. We saw a situation where a client sent in a letter that made a change for the main contact on a PMA. That one page letter was a PMA amendment and need its very own eCopy and a cover letter.
  • eCopy is a bit of a misleading name. FDA guidance informs us that eCopy and eSubmission are different and we should not confuse them. An eSubmission is a collection of files electronically that are put together by the eSub software that are the official copy of what you submitted. The eCopy is the collection of electronic files that the eSub software assembles that is the official copy of your submission. Are you confused yet? We are. Oh, and FDA also tells us that ODE and OIVD accepts eSubmission by eCopy.
  • Digital information is now primary and paper is secondary. eCopy is now the real, official copy, but this is undermined by two new rules. First, submissions that need several copies only need a single paper copy. Any other copies may be electronic. Then, FDA tells us that you can duck printing large volumes of stuff that only make any sense in electronic form, such as a line listing.
  • Validation is a bear – start it early! Most FDA requirements are fairly easy. You will need to do a cover letter, use common name conventions, limited file size and so forth. But the rules on no attachments and no security settings? Tougher. Many things can add attachments invisibly to PDFs without any change to the content or their usage. FDA seems aware of this because they provide an example of a joboptions attachment that features invisible instructions that are only used by Distiller. It can be hard to dump these attachments. This is especially true if you want to keep graphics, fonts, bookmarks and hyperlinks that make the document usable. It is easy to see why FDA is worried about attachment abuse. But we think rejecting documents due to application enhancements or invisible files is going too far.

We have a Webinar coming up April 10 that will fully detail how to submit an eCopy-compliant submission.


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