19 July 2012

CSC: What was the part in the middle? FDA's Module 1 v2 - Applications, Submissions and Sequences - By Joel Finkle

The question above is the response of Otto, the dimwitted assassin brilliantly played by Kevin Kline in the movie "A Fish Called Wanda" when presented with too many choices. While not really applicable to FDA's Module 1 version 2, which is coming regardless, it's the middle part that has caused a lot of confusion, and it needs to get more complex, while at the same time become more clear... got it?

Let's take it from the top: FDA's eCTD submissions have always included three numbers: An application number (NDA, aNDA, BLA, or IND), a sequence number (starting at 0000), and a related sequence number. There has always been confusion about the related sequence number, and despite several FDA presentations, sequencing has been a common source of errors in filing an eCTD.

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