FDA has published a new guidance on eCTD 4.0

By 5. October 2017Blog

Yesterday US FDA has published a new guidance “M4 Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use – Guidance for Industry”. FDA has addressed recommendations for eCTD 4.0. The guidance also provides separate tables describing the recommended granularity for paper and eCTD v3.2.2 submissions, and for paper and eCTD v4 submissions.

https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073257.pdf

Also, in another new guidance, FDA clarifies that for DMF information submitted in an ANDA, electronically submitted DMF information will be considered readily available if the Right of Reference letter clearly indicates the exact location of the relevant information within the DMF – the eCTD sequence and submission date.

https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM578368.pdf

Author Rainer Schwarz

Cunesoft CEO – He has over 15 years of experience with compliant software solutions for regulated processes. He worked in senior management positions at CDC Solutions, Liquent and NextDocs. He has a
master degree of Social Sciences from the University of Innsbruck and Hong Kong University

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