News Archiv

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

14.08.2012
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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]

[more]

FDA updates Study Data Specifications and Transmission Specifications

03.08.2012
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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]

[more]

FDA releases draft guidance for standardized study data

22.02.2012
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The U.S. Food and Drug Administration (FDA) has released a new draft guidance document "Providing Regulatory Submissions in Electronic Format — Standardized Study Data"....[more]

[more]

Update: FDA releases new minor version of PDF specifications

25.01.2012
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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]

[more]

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

06.01.2012
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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]

[more]

FDA releases draft Module 1 specification v2.0 - not for implementation

27.10.2011
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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]

[more]

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

07.09.2011
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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]

[more]

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