Year: 2024
-
ICH E2D Guidelines update
The ICH E2D(R1) draft Guideline on “Post-Approval Safety Data: Definitions and Standards for Management and Reporting of individual Case Safety Reports” reached reached Step 2 of the ICH process on 5 February 2024. The ICH E2D guideline provides guidance on definitions and standards for post-approval individual case safety reporting, as well as good case management…
-
FDA safety communication on smart devices that claim to measure blood glucose
Reference: https://www.fda.gov/medical-devices/safety-communications/do-not-use-smartwatches-or-smart-rings-measure-blood-glucose-levels-fda-safety-communication
-
Update to EudraVigilance – EVWEB User Manual
EVWEB user manual is part of the official documentation prepared by the European Medicines Agency (EMA) to support the use of the EudraVigilance Web reporting tool (EVWEB). The Manual has been updated to version 1.7 (29 February 2024). Revision 1.7 contains the following updates: Reference: Click to access eudravigilance-evweb-user-manual_en.pdf
-
Medical devices Annual reports – TGA guidance
The sponsor of a medical device that is: Then the sponsor should submit three consecutive annual reports to TGA after the device is included in the ARTG as a post marketing obligation. The submission of annual reports is part of the device lifecycle approach for the sponsor to demonstrate that: Due dates and reporting periods:…