Mar 193 mineCTD Guidance Updates – What’s New in 2020FDA has released several updates to eCTD Guidances
Oct 24, 20193 minDrug Master Files: Highlights of the Updated FDA GuidanceOn October 18, 2019, FDA released an updated draft Guidance regarding Drug Master Files (DMFs) titled “Drug Master Files Guidance for Industry”. This is the ...
Oct 3, 20192 minNew Draft FDA Guidance: Electronic Format for Medical Device SubmissionsOn September 26, 2019, the FDA released a new draft guidance document titled “Providing Regulatory Submissions for Medical Devices in Electronic Format — Sub...
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 accelerated approval ...
Jul 31, 20192 minFDA 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. The Original draft gui...
