This guidance and the technical specification documents it incorporates by reference describe how sponsors and applicants must organize the content that they submit to the Agency electronically for all submission types under section 745A(a) of the FD&C Act. In addition to this guidance and existing technical specification documents, further and more detailed technical instructions are included in a separate eCTD technical conformance guide. This guidance implements the electronic submission requirements of section 745A(a) of the FD&C Act for the electronic format of the content submitted in new drug applications (NDAs), abbreviated new drug applications (ANDAs), certain biologics license applications (BLAs), and certain investigational new drug applications (INDs) to the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER).


Posted on the FDA website on 29 January 2019