News Archive

CDER to issue 3rd Acknowledgement for Successful eCTD Submissions

19.05.2016
Flag of USA

Beginning May 31, 2016, CDER will begin issuing an acknowledgement to FDA Electronic Submissions Gateway (ESG) users when their NDA, ANDA, BLA, IND or DMF submission has...[more]

FDA releases final guidance for certain human pharmaceutical product applications; mandates eCTD submissions

19.05.2015
Stars and Stripes

The Food and Drug Administration (FDA) has finally released the final Guidance for Industry "Providing Regulatory Submissions in Electronic Format —Certain Human...[more]

FDA revises example submission code using the new Module 1 version 2.3

21.04.2015
Flag of USA

The FDA has released some some revised information related to the forthcoming new Module 1 version 2.3 which is targeted to come into effect in Q3 2015. The revision concerns the...[more]

FDA updates Study Data Technical Conformance Guide

19.03.2015
Flag of USA

The U.S. Food and Drug Administration has released a new version 2.1 of the "Study Data Technical Conformance Guide", dated March 2015.

The new version 2.1 takes into...[more]

FDA releases PDF specification 4.0

07.10.2014
Flag of USA

The U.S. Food and Drug Administration (FDA) has released a new version 4.0 of their "Portable Document Specifications (PDF)". The PDF specification itself is referenced...[more]

FDA issues new draft for electronic submissions of Postmarketing Safety Reports

04.07.2014
Flag of USA

The U.S. FDA has released a new draft guidance, dated June 2014 Providing Submissions in Electronic Format - Postmarketing Safety Reports This new draft revises and supersedes the...[more]

FDA ESG provides new WebTrader Hosted Solution as alternative to the ESG

30.05.2014
Flag of USA

The US FDA has recently notified users of the Electronic Submissions Gateway (ESG) of a new capability which will be available starting June 01, 2014 - The WebTrader Hosted...[more]

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