FDA is announced the availability of a final guidance for industry entitled “Providing Regulatory Submissions in Electronic Format: IND Safety Reports.” This guidance describes the electronic format, sponsors will be required to use when they electronically submit to the FDA, IND safety reports for serious and unexpected suspected adverse reactions …
The Medical Dictionary for Regulatory Activities (MedDRA) is a terminology developed by the International Council for Harmonisation (ICH). While it is useful for precise coding of adverse events of medicines for data analysis, its high granularity can obscure the communication of adverse reactions in product labeling for healthcare practitioners. Many …
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 …
Reference: https://www.fda.gov/medical-devices/safety-communications/do-not-use-smartwatches-or-smart-rings-measure-blood-glucose-levels-fda-safety-communication
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
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: …