Jul 22, 20203 minFDA Ad-Promo Series: 2253 Submissions in eCTD FormatWAYS describes the documentation required for 2253 submissions in eCTD format
Sep 6, 20194 minFDA Ad-Promo Series: Navigating eCTD Submissions for Accelerated Approval ProductsBackground on Subpart H/E Products For life-threatening diseases where there is no current marketed treatment, the FDA may allow for an...
