Format Tweaks Needed Between FDA, EMA eCTD Submissions

Washington Drug Letter
Drugmakers submitting electronic common technical document (eCTD) marketing applications to both the FDA and European Medicines Agency (EMA) can basically clone their submissions but the format must be reworked to meet the needs of each agency, an eCTD expert advises.

To View This Article:


Buy This Article Now

Add this article to your cart for $25.00