Feb 21, 20221 mineCTD Module 1 Specification ReminderO March 1, 2022, the US FDA will no longer be accepting the eCTD Module 1 specification v1.3 (US regional DTD v2.01)
Mar 19, 20203 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Oct 24, 20193 minDrug Master Files: Highlights of the Updated FDA GuidanceOn October 18, 2019, FDA released an updated draft Guidance regarding Drug Master Files (DMFs) titled “Drug Master Files Guidance for...
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Draft FDA Guidance: Electronic Format for Medical Device SubmissionsOn September 26, 2019, the FDA released a new draft guidance document titled “Providing Regulatory Submissions for Medical Devices in...