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Re: Format for submission to FDA

From: Pravin Jadhav <pravinj>
Date: Mon, 29 Jun 2009 23:33:41 -0400

Hi Dennis et. al.

The electronic gateway at FDA has adopted the SAS XPT as a standard.
According to my understanding, they have discontinued the old ASCII format
or are in the process of doing so. You can find more useful links at with FAQs.

If the software is highly specialized, you may explore alternative ways of
data submission (CD-ROM etc.) by consulting with the regulatory liaisons
(requires a combination of paper and electronic submission). However, for
several reasons I would recommend taking slightly extra effort to convert
files to SAS XPT format. It helps to maintain the process and ensure the
central availability of information. Please note that POPPK/PD/modeling
datasets constitute only a minor fraction of data received by FDA.

Hope it helps.

On Mon, Jun 29, 2009 at 6:20 PM, MIDO (Michael Dodds) <doddsm

> All,
> I would also be very interested in your responses. Recently, we've
> attempted to submit a Berkeley Madonna file as part of a submission, and
> that file type has caused some problems. While it is possible to take the
> BM code out as a flat .txt and the embedded data set out as a .csv or .xls
> (or even .xpt, I suppose), I questioned the utility of that.
> "Reconstituting" the analysis from the components might be possible here,
> but it's error prone and, frankly, inefficient.
> In the end, we were able to simple embed the BM file (extension .mmd) into
> the eCTD format and send it along. Someone without the BM tool installed on
> their computer would receive a puzzled response from their web browser when
> trying to open the file. However, someone with the tool installed is able
> to correctly open the BM file.
> Again, comments from our regulatory colleagues would be very helpful here.
> How can we package and transport complex analysis (my example was single BM
> file, Dennis suggests a series of NONMEM runs in a file structure) and share
> that with regulatory bodies?
> Regards,
> Mike Dodds
> -----Original Message-----
> From: owner-nmusers
> On Behalf Of Dennis Fisher
> Sent: Monday, June 29, 2009 1:36 PM
> To: nmusers
> Subject: [NMusers] Format for submission to FDA
> Colleagues,
> One of my clients is approaching submission of an NDA to FDA. I did
> the pop PK analysis; the files that I generated are in three formats -
> text, PDF, and csv. NONMEM text output is saved in two formats (text
> and PDF); NONMEM tables are saved in two formats (text and csv);
> graphics created in R are saved in PDF format. Datasets used for each
> step of the analysis are archived in two formats, text (an exact copy
> of the input file plus an exact copy of the FDATA file) and csv (the
> FDATA file formatted as csv).
> Our plan (based on my other recent submissions to FDA, none of which
> has elicited any complaints from them), was to submit these documents
> in the formats described above. However, my client received a request
> from FDA that:
> "datasets [used in the analysis] should be submitted as SAS
> transport
> (*.xpt) files".
> In addition, the company managing the submission wants to convert all
> my other csv files to xpt format (although there was no specific
> request for this).
> Can anyone (particularly anyone at FDA) clarify this for me? In that
> NONMEM will not accept .xpt files, I am surprised that FDA would want
> datasets in that format. Should my client honor the request or should
> they explain to the project manager that NONMEM requires text files so
> we plan to submit these files in text format (either .txt or csv).
> Thanks for any insights on this.
> Dennis
> Dennis Fisher MD
> P < (The "P Less Than" Company)
> Phone: 1-866-PLessThan (1-866-753-7784)
> Fax: 1-415-564-2220
> <>

Received on Mon Jun 29 2009 - 23:33:41 EDT

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