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FDA: Increase of eCTD submissions of DMF

FDA presented the number of eCTD applications for Drug Master Files

FDA presented the number of eCTD applications for Drug Master Files
July 3, 2015

FDA reported that the preferred format for DMF applications is eCTD format and last year the percentage of eCTD´s for DMF submissions has increased.

In addition from 15 June 2017, eCTD will become mandatory, not only for DMF, but also for NDA, ANDA and BLA.

Last but not least, for the sponsor, the eCTD format shows benefit to use as there is a higher percentage for 1st cycle complete rate.

For eCTD the completion rate is nearly 50%, while for paper the percentage does not reach the 20%.

Asphalion has extensive experience in the preparation of DMF’s in eCTD format.
In addition, Asphalion can arrange the submission to the FDA by Gateway, which guarantees delivery within a matter of minutes.
If you have any question about our services, please contact

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