eCTD Guidance Updates – What’s New in 2020
FDA has released several updates to eCTD Guidances
top of page
We Are Your Solution
Search
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...
385 views0 comments
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...
796 views0 comments
"WAYS OF WORKING" BLOG
bottom of page