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Home » FDA to Require eCTD Submissions By 2016: Draft Guidance
FDA to Require eCTD Submissions By 2016: Draft Guidance
January 11, 2013
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NDAs, BLAs and ANDAs will need to be submitted electronically in about 36 months under the third revision of an FDA draft guidance on electronic common technical documents (eCTD) released Jan. 3.