US FDA: Electronic Copies for Premarket Submissions
13/02/2013 20:14
Food and Drug Administration Safety Innovation Act (FDASIA) requires the submission of electronic copies (eCopies) for most premarket submissions. An eCopy is defined as an exact duplicate of a paand per submission that is created and submitted on a compact disc (CD), digital video disc (DVD), or flash drive. It is not an electronic submission.
Beginning January 1, 2013, the FDA will only place a premarket submission under review if it has an eCopy that has been validated by FDA's eCopy loading system.
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European Union
+49 89 21550998
China
+86 131 6119 7082
United States
+1 805 570 6135
info@ecu