Update: FDA releases new minor version of PDF specifications

Update to News from Jan 04, 2012: Meanwhile, FDA has released a new minor version 3.1 of the PDF specification (see original News below). The minor update includes clarification...[more]

FDA releases new version of their eCTD validation criteria and updates transmission specification

The U.S. Food and Drug Administration (FDA) has released a new version of their eCTD validation criteria. The new version 2.1 is dated 12/20/2011 and contains significant changes...[more]

FDA releases draft Module 1 specification v2.0 - not for implementation

The U.S. Food and Drug Administration (FDA) has published the draft "eCTD Backbone Files Specification for Module 1 Version 2.0" together with the updated...[more]

PDUFA V draft performance goals and procedures foresee mandatory eCTD submissions for human medicinal products in U.S.

The U.S. Food and Drug Administration (FDA) has published the draft PDUFA V (Prescription Drug User Fee Act) "Reauthorization Performances Goals and Procedures Fiscal Years...[more]