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www.fdanews.com/articles/169204-final-guidances-clarify-esubmission-expectations-for-applications-study-data

Final Guidances Clarify eSubmission Expectations for Applications, Study Data

December 17, 2014

In two years’ time, manufacturers must submit applications for NDAs, ANDAs, INDs and BLAs using a set of approved electronic formatting standards, which the FDA finalized yesterday.

The final guidances, covering general submissions and study data, outline the acceptable file standards that were called for under the 2012 Food and Drug Administration Safety and Innovation Act. The final versions carry over suggestions from the drafts. The agency will support:

  • File format standards such as Adobe Acrobat Portable Document (.pdf), SAS Institute 111 Transport File format (.xpt), text files (.txt) and Extensible Markup Language (.xml);
  • Study data exchange standards such as CDISC’s Study Data Tabulation Model (SDTM);
  • Analysis standards such as CDISC’s Analysis Data Model (ADaM); and
  • Terminology standards, including the National Drug File reference terminology for drug classifications, CDISC controlled terminology and the Medical Dictionary for Regulatory Activities (MedDRA).

The final guidances also clarified that the standards should be used for NDAs and ANDAs, as well as for some BLAs and INDs. But neither guidance applies to devices regulated as biologics or noncommercial INDs, the agency said, addressing earlier confusion on the issue.

In addition, the final guidances confirm that drugmakers may apply for waivers to use different versions of previously approved submissions formats. The FDA will inform a drugmaker within 30 days of receiving a wavier as to its status, allaying concerns that the draft guidance did not hold the agency to reviewing waivers in a timely manner.

Companies will have 18 months to implement any updates to new versions of the standards, up from the original 12-month period called for in the draft. Some drugmakers commenting on the draft had requested 24 months to make these changes (DID, May 8).

View Providing Regulatory Submissions in Electronic Format – Standardized Study Data at www.fdanews.com/12-17-18-Studydataguidance.pdf and Providing Regulatory Submissions in Electronic Format – Submissions Under Section 745A (a) of the Federal Food, Drug and Cosmetic Act at www.fdanews.com/12-17-14-745Aguidance.pdf. — Lena Freund