FDA Drug Safety Review Will Consider Pros And Cons Of Separate Safety Agency
This article was originally published in The Pink Sheet Daily
Executive Summary
The agency is in discussions with the Institute of Medicine to initiate a study on the effectiveness of the drug safety system, particularly in the post-marketing phase. The IoM study is the centerpiece of an FDA drug safety initiative, announced Nov. 5, that packages together ongoing projects.
You may also be interested in...
Lack Of Funding Has "Hobbled" FDA Postmarketing Drug Safety Work – IoM
Substantially increased resources are needed to improve FDA's drug safety activities and implement IoM recommendations, report says.
Sweeping Changes At CDER Recommended In IoM Drug Safety Report
Among solutions suggested is six-year fixed term for the FDA commissioner and appointment of external advisory board to oversee cultural changes.
Lack Of Funding Has "Hobbled" FDA Postmarketing Drug Safety Work – IoM
Substantially increased resources are needed to improve FDA's drug safety activities and implement IoM recommendations, report says.