13 August 2012

FDA: New Study Data Exchange Format – Requesting Comments & Holding Meeting

The FDA is requesting comments from industry and the public on the development of standards for study data exchange standards.
In Federal Register notice, FDA mentioned that they are holding a meeting to assess the suitability of the current study data exchange format, the ASCII-based SAS Transport (XPORT) version 5 used by its drugs, biologics and devices regulatory centers and also mentioned that this meeting will be geared toward understanding the costs and benefits of moving to a new study data exchange standard and determining the next steps to formulate a plan of action.
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