HL7 Stability Standard Implementation Guide Teleconference Minutes 2014-02-10

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HL7 Stability Standard Teleconference Minutes

February 10, 2014

Attendees: Norman Gregory (CVM), Tim Lee (CBER), Tena Wei (CDRH), Mike Mlodzik (Boehringer Ingelheim Vetmedica, Inc.), Mike Yang (ScienTek Software), Art Griesser (Promethues), Sandra Spiewak (Reed Technology and Information Services Inc.), Sam Dana (Promethues), and Stan Altan (Johnson & Johnson)

  • When using eSubmitter for CBER stability data can be attached as an xml file. The file types that are acceptable are .pdf, .jpg, .gif, .tif, .avi, .wmv,.xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip, .doc, and .docx
  • Tested eSubmitter attaching a stability report in xml format for an annual report to a New Animal Drug Application and it worked. When you click on the xml stability report it opens it in the style sheet.
  • When using eSubmitter for CDRH you can only add non-PDF files as Statistical Data (SAS, XPORT, XML, SGML, S-Plus, R files, ASCII, Molfiles and Excel) or Misc Files (.gif, .tif, .jpg, .avi, .mpeg, .wmv, and .txt). See http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM313794.pdf
  • CVM will post an announcement that eSubmitter will accept stability reports in XML format along with an expected time frame for only accepting stability reports in the XML format.
  • If you are submitting a paper submission to CVM you can have the stability report as an xml file on a CD.

• CVM is receiving over 60% of submissions in eSubmitter and Center for Tobacco Products only uses eSubmitter.

  • The editor is available for download at https://module3solutions.com/ If you have downloaded it and got a "Failure sending mail" message. launch the application again. It will bring you back to License key request page. Take a screen shot of the page and email it to info@module3solutions.com. You will then be sent a key. Some SMTP servers are blocking the message.
  • You can go to www.xmlstability.com for another source for creating xml eStability reports.
  • There will be no teleconference 2/17/14, next teleconference will be 2/24/14.

Agenda for February 24, 2014 Teleconference: