FDA Sets Date for Electronic Drug Submission Filings
Drugmakers submitting NDAs, ANDAs, INDs and BLAs must use approved electronic formatting standards beginning March 15, 2018.
The FDA wants companies to use the Clinical Data Interchange Standards Consortium Study Data Tabulation Module Implementation Guide version 3.2 in regulatory submissions to CBER and CDER. The guide is ready, with a few exceptions, and the FDA is encouraging firms to begin using it now even though the deadline for complying is more than two years away.
Those exceptions are the sections in SDTM IG 3.2 on death details and exposure as collected, which have not completed testing and acceptance, and are not ready for use, according to a notice in today’s Federal Register. Some therapeutic area standards also aren’t supported at this time, the notice says.
Today’s notice of the transition date for version 3.2 is required within the December 2014 final guidance spelling out the use of electronic formatting standards. The FDA will support the following file formats: Adobe Acrobat Portable Document (.pdf), SAS Institute 111 Transport File format (.xpt), text files (.txt) and Extensible Markup Language (.xml) (DID, Dec 18, 2014).
Companies are required to begin transitioning to the new system by March 15, 2017.
While the final guidance exempts noncommercial INDs, the agency says it will accept voluntary electronic format submissions from their sponsors.
Read the Federal Register notice at www.fdanews.com/08-18-15-version32.pdf. — John Bechtel
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