Electronic Common Technical Document Technical Conformance Guide; Availability

The Food and Drug Administration (FDA) is announcing the availability of an Electronic Common Technical Document (eCTD) Technical Conformance Guide, Version 1.0. The eCTD Technical Conformance Guide supplements the guidance for industry entitled ``Providing Regulatory Submissions in Electronic Format--Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specification'' and provides specifications, recommendations, and general considerations on how to submit eCTD-based electronic submissions to the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER).