NONMEM Users Network Archive

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RE: Format for submission to FDA

From: Lavigne, Jean <Jean.Lavigne>
Date: Tue, 30 Jun 2009 10:43:45 -0400

Dear Dennis,

Please see the FDA guidance (Providing Regulatory Submissions in =
Electronic Format) in the web link below at page 7; the ASCII files =
(e.g. NONMEM) should have the txt extension.

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformatio=
n/Guidances/ucm072349.pdf

Jean


--------------------------------------------
Jean R. Lavigne M.Sc.
Associate Director, Clinical Pharmacology
MDS Pharma Services
4705 Dobrin
St-Laurent, Québec, Canada
H4R 2P7
Phone: (514) 333-0042 ext. 54234
e-mail: jean.lavigne
--------------------------------------------

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-----Original Message-----
From: owner-nmusers
On Behalf Of Dennis Fisher
Sent: Monday, June 29, 2009 16:36
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

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Received on Tue Jun 30 2009 - 10:43:45 EDT

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