Draft Guidance: FDA to Require eCTD Submissions for New Applications by 2016

All INDs, NDAs, BLAs and ANDAs will need to be submitted electronically in about 36 months under the third revision of an FDA draft guidance on electronic common technical documents (eCTD) released Thursday. The guidance may bring some relief for drugmakers as it does not require previous submissions to be resubmitted in electronic format, Antoinette Azevedo, founder of e-SubmissionsSolutions.com, said.
Drug Industry Daily