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)
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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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Oct 24, 20193 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On October 18, 2019, FDA released an updated draft Guidance regarding Drug Master Files (DMFs) titled “Drug Master Files Guidance for...
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Oct 3, 20192 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On September 26, 2019, the FDA released a new draft guidance document titled “Providing Regulatory Submissions for Medical Devices in...
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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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Jul 31, 20192 min read
FDA Ad-Promo Series: The Guidance Has Been Finalized – What’s Next For Sponsors?
On June 21, 2019, FDA released the Finalized Guidance for Promotional Labeling and Advertising Materials for Human Prescription Drugs....
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