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FDA Ad-Promo Series: 2253 Submissions in eCTD Format
WAYS describes the documentation required for 2253 submissions in eCTD format
Jul 22, 2020
3 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...
Sep 6, 2019
4 min read
"WAYS OF WORKING" BLOG
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