Zdrowie i gospodarka · 24/02/2020

FDA Requests Comments on Electronic Common Technical Document v4.0 Technical Conformance Guide and Implementation Package

The US Food and Drug Administration (FDA) is seeking public comment on the draft Electronic Common Technical Document (eCTD) v4.0 Technical Conformance Guide and the FDA eCTD v4.0 Module 1 Implementation Package, which outline specifications for submitting eCTD v4.0-based electronic submissions to the FDA.