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KNOWLEDGE CENTER

CDER CBERs eCTD standard format Jan 2017

The Electronic Common Technical Document (eCTD) is CDER/CBER’s standard format for electronic regulatory submissions.Beginning May5, 2017 submission type NDA, ANDA,BLA and Master Files must be submitted in eCTD format.Commercial IND submissions must be submitted in eCTD format beginning May 5, 2018.



Structured Product Labeling SPL

When discussion takes on to Structured Product Labeling (SPL) often most of our thoughts move to prescribing information. However the US food and drug administration (USFDA) and other regulatory authorities overhaul review procedures, electronic fillings are having a strong effect on the communications.



Operational Similarities and Differences : USA VS EU

Given the globalization of the biopharma industry, consorting the drug regulatory environs of the United States of America (USA) and European Union (EU) are getting more and more important to fasten the development of new curatives.



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