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Mar 19, 20203 min read
eCTD Guidance Updates – What’s New in 2020
FDA has released several updates to eCTD Guidances
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Jan 23, 20205 min read
Simultaneous US/EU Submissions: 5 Tips for Success
Introduction The US NDA and EU MAA applications are complex projects that take careful strategic planning and time management. The two...
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Sep 6, 20194 min read
FDA Ad-Promo Series: Navigating eCTD Submissions for Accelerated Approval Products
Background on Subpart H/E Products For life-threatening diseases where there is no current marketed treatment, the FDA may allow for an...
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