News Archiv

FDA releases final version 2.0 of the US eCTD Module 1 specification

The U.S. Food and Drug Administration (FDA) has released the final version 2.0 of the regional US eCTD Module 1 specification files.

The Module 1 eCTD specification files have...[more]

FDA updates Study Data Specifications and Transmission Specifications

The U.S. Food and Drug Administration (FDA) has released an updated version 2.0 of their Study Data Specification, dated July 18, 2012.

The specification document was reorganized...[more]

FDA releases draft guidance for standardized study data

The U.S. Food and Drug Administration (FDA) has released a new draft guidance document "Providing Regulatory Submissions in Electronic Format — Standardized Study Data"....[more]

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FDA releases draft Module 1 specification v2.0 - not for implementation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