USA – FDA Finalizes eCTD Guidance, Consults on eCTD v4.0 Technical Documents

The US Food and Drug Administration (FDA) on Friday finalized the seventh revision to its guidance on making regulatory submissions in electronic common technical document (eCTD) format to specify cases where an exemption or waiver from eCTD requirements is warranted.
 
The 17-page guidance finalizes a draft version released in July 2019 and replaces the previous final version from January 2019.
 
Within the guidance, FDA says it will exempt all Type III drug master files (DMFs) from eCTD requirements, in addition to noncommercial investigational new drugs (INDs)…