Extracting Information from PDF Forms Ranks as No. 1 FDA Processing Issue

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At a  GPhA/FDA Labeling Workshop on April 14, 2010, Virginia Ventura of CDER’s Office of Business Informatics presented CDER Update eCTD & Gateway Submissions.  Along with lots of other useful information, Ms. Ventura provided an assessment of the current Top Processing Issues with Esubs:

Description Percent of total
Unable to extract info from PDF form (sponsor did not use fillable form) 52%
Missing form (356h, 1571 or 2252) 13%
Bad Characters (per eCTD Spec) in file or folder names 10%
Duplicate sequence (sponsor sent twice) 10%
“High” validation errors 7%
Media empty or corrupted 4%
Wrong application number in us-regional.xml 2%
Invalid submission type identified (eCTD submitted as non-eCTD or vice versa) 1%
Valid application number with incorrect type (combination is valid but not Sponsor’s application) 1%


Certainly, the high percentage of submissions not using fillable forms is startling – Ms. Ventura mentioned that most of these are ANDAs. She spells out the solution for using 356h fillable forms (including their correct use with annual reports) – consult the presentation for details. She also stresses that the correct use of fillable forms results in your submission getting to the reviewer much quicker (best case an amazing 10 minutes!).

The amount of High Severity validation errors is also concerning, as the presentation reiterates what the FDA has said before – High Errors = Submission cannot be accepted.  Therefore, up to 7% of these submissions may have been rejected, resulting in time off the PDUFA clock in many cases.

All of this serves as a wake-up call that validation and submission QC are more important than ever. Be sure to read the presentation for more tips on STFs, QC of us-regional.xml, use of the gateway, and many other quality issues and considerations.

Author: GS

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