Adverse Event Reporting Harmonization Is Goal Of Joint FDA/NIH Task Force
Executive Summary
An HHS task force is preparing to release a guidance on harmonizing the federal government's clinical adverse event reporting policies
You may also be interested in...
Sponsors Should Manage Adverse Event Reports To Reduce IRB Burden – Lilly
Sponsors should be responsible for oversight of adverse event safety data review to reduce institutional review board burden, Lilly Project Leader Vish Watkins says
Sponsors Should Manage Adverse Event Reports To Reduce IRB Burden – Lilly
Sponsors should be responsible for oversight of adverse event safety data review to reduce institutional review board burden, Lilly Project Leader Vish Watkins says
Aleve Warning Gives Pfizer Some Relief, But Is New Headache For FDA
Data from a National Institutes of Health study on Alzheimer's disease prevention showing a cardiovascular safety signal for naproxen present a new challenge for FDA in regulating COX-2 inhibitors