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eCTD Module 1 Specification Reminder
O March 1, 2022, the US FDA will no longer be accepting the eCTD Module 1 specification v1.3 (US regional DTD v2.01)
Feb 21, 20221 min read
eCTD Guidance Updates – What’s New in 2020
FDA has released several updates to eCTD Guidances
Mar 19, 20203 min read
Drug Master Files: Highlights of the Updated FDA Guidance
On October 18, 2019, FDA released an updated draft Guidance regarding Drug Master Files (DMFs) titled “Drug Master Files Guidance for...
Oct 24, 20193 min read
New Draft FDA Guidance: Electronic Format for Medical Device Submissions
On September 26, 2019, the FDA released a new draft guidance document titled “Providing Regulatory Submissions for Medical Devices in...
Oct 3, 20192 min read
"WAYS OF WORKING" BLOG
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