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 ?
