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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