Posts Tagged ‘MedWatch’

Post-Market Surveillance Of Drug Safety

This is the final post in our brief series on drug safety. If you missed any of the previous posts, here are the links: Why Monitoring Adverse Events And Drug Safety Signals Matters What Exactly Is An “Adverse Drug Reaction?” The Role Of Signal Detection In Drug Safety What Pharmacovigilance Means And Why It Matters […]

The Troubles With Adverse Event Reporting

  According to the September/October edition of the Impact Report released by the Tufts Center for the Study of Drug Development (CSDD), the reporting of adverse events (AEs) by healthcare professionals is inadequate. In particular, regulatory submissions are an issue due to the lack of critical information provided on submission forms, which can inadvertently alter […]

When The System Fails To Keep Us Informed Of Adverse Events

  I just read “Failing To Report Severe Drug Side Effects: A National Embarrassment,” written by Forbes contributor Luke Timmerman. He talks about his recent personal experience with our health system and what he believes is poor adherence to the reporting of adverse events. Why should patients or their loved ones have to demand that […]

4 Ways To Submit A MedWatch 7-Day Report

Over the years we have seen some general confusion regarding the use of the FDA MedWatch 7-day report for fatal blood collection or transfusion reporting versus the standard 7-day alert requirement for FDA individual case safety reports from IND trials. Some of the safety systems that our company has worked with over the years do […]