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Monthly Archives: February 2017

FDA’s Mandatory eCTD requirements ? Are you ready ? February 25, 2017

FDA eCTD  format – Electronic Common Technical Document From the beginning of  May 5, 2019,  FDA requires, ANDA, NDA, and Master Files regulatory submission in eCTD  format. Since FDA is mandating electronic submission  requirements from May 5, 2019 for all the  future amendments, annual reports , supplements or any such regulatory filings. But, it is  not mandatory … Continue reading FDA’s Mandatory eCTD requirements ? Are you ready ?

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