Electronic Drug and Biologic Submissions

[membership level=”0,4″][The content continues for paid members only.] Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership] In early May, FDA published a final guidance on electronic common technical document (eCTD) submissions. Per provisions in the FDA Safety and Innovation Act (FDASIA) section 1136, the guidance publication begins a two-year countdown to the requirement for all new drug and biological product submissions to be sent to the agency electronically. Commercial INDs will have a year longer to comply – until May 2018. EMA announced earlier this year that all drug application submissions must be in electronic format beginning on July 1, 2015 (see IPQ “Monthly Update” Jan./Feb. 2015 p. 45).
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