FDA revised guidance on providing master file submissions in eCTD format. The update adds a paragraph to the introduction describing the rational for changing the timetable from 24 to 36 months for required submissions. “FDA has determined, in response to industry comments and internal review, that it is appropriate to extend the required date to submit master files in electronic eCTD format by 1 year to May 5, 2018.” The revision also adds an example timetable.
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