News Archive

CDER to issue 3rd Acknowledgement for Successful eCTD Submissions

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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

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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

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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

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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

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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

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The U.S. FDA has released a new draft guidance, dated June 2014 Providing Submissions in Electronic Format - Postmarketing Safety Reports This new draft revises and supersedes the...[more]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

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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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