FDA CDER eCTD Update: Importance of the Study Tagging File

| 01 June 2010

A few years ago, sponsors and others would frequently ask me if all the FDA drug review divisions were "prepared" to receive eCTDs. At first this seemed an odd question, as the Center for Drug Evaluation and Research (CDER) adopted the eCTD as a submission standard in 2003 and has vigorously encouraged its use since that time. In fact, since accepting our very first eCTD, CDER has received more than 112,000 submissions in this format.


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