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/GuidanceComplianceRegulatoryInformation/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: [email protected] -------------------------------------------- MISE EN GARDE CONCERNANT LA CONFIDENTIALITÉ Ce courriel et tout autre fichier transmis avec lui peut contenir des informations protégées et/ou confidentielles et ne doit être lu ou utilisé que par le destinataire visé. Si vous n'êtes pas le destinataire visé de ce courriel ou de ses pièces jointes, soyez avisé que vous avez reçu ce courriel par erreur et qu'il est strictement interdit de diffuser, distribuer, transférer, imprimer ou copier ce courriel ou tout fichier joint. Si vous avez reçu ce courriel par erreur, veuillez l'effacer immédiatement ainsi que toutes les pièces jointes et aviser l'expéditeur par retour de courriel ou le contacter au numéro indiqué. -----Original Message----- From: [email protected] [mailto:[email protected]] On Behalf Of Dennis Fisher Sent: Monday, June 29, 2009 16:36 To: [email protected] 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 </PRE>This e-mail and any files transmitted with it may contain privileged and/or confidential information and may be read or used only by the intended recipient. If you are not the intended recipient of the e-mail or any of its attachments, please be advised that you have received this e-mail in error and any use, dissemination, distribution, forwarding, printing or copying of this e-mail or any attached files is strictly prohibited. If you have received this e-mail in error, please immediately purge it and all attachments and notify the sender by reply e-mail or contact the sender at the number listed.
