NONMEM Users Network Archive

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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.
http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM163561.pdf
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
http://www.sas.com/govedu/fda/index.html 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.
Pravin


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
> www.PLessThan.com <http://www.plessthan.com/>
>
>
>
>

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

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