Zdrowie i gospodarka · 24.02.2020
Electronic Common Technical Document v4.0 Technical Conformance Guide; Food and Drug Administration Electronic Common Technical Document v4.0 Module 1 Implementation Package; Request for Comments
The Food and Drug Administration (FDA or the Agency) is requesting comment on the draft Electronic Common Technical Document (eCTD) v4.0 Technical Conformance Guide and the FDA eCTD v4.0 Module 1 Implementation Package. The eCTD v4.0 Technical Conformance Guide will provide specifications, recommendations, and general considerations on how to submit eCTD v4.0-based electronic submissions to the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER) using the International Council for Harmonisation eCTD v4.0 Implementation Package and the FDA eCTD v4.0 Module 1 Implementation Package. The Agency is seeking comment on the eCTD v4.0 Technical Conformance Guide and the FDA eCTD v4.0 Module 1 Implementation Package for the accuracy, suitability, and appropriateness of these specifications for the submission of eCTD v4.0 submissions. These versions of the documents are not for implementation.