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Guide on Electronic Common Technical Document


Federal Register Notice: FDA is making available an Electronic Common Technical Document (eCTD) Technical Conformance Guide, Version 1.0. The 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 CDER or CBER. To download this guidance, click here. To view this notice, click here.