Making the Grade: Reviving the New Drug "Report Card"
This article was originally published in RPM Report
Executive Summary
The Food & Drug Administration is proposing the development of a pilot program to assess and communicate post-marketing experience for newly approved drugs and biologics. The pilot, which is part of FDA's response to the Institute of Medicine report on drug safety, is a revival of the "report card" idea from the late 1990s.
You may also be interested in...
FDA Drug Safety Update: Key Takeaways From IoM Workshop
It has been three years since an Institute of Medicine report on FDA's drug safety system, and two years since the landmark FDA Amendments Act that followed. As those anniversaries approached, IoM convened a workshop for an update on the changes at FDA since FDAAA. Here's what we heard.
FDA Drug Safety Update: Key Takeaways From IoM Workshop
It has been three years since an Institute of Medicine report on FDA's drug safety system, and two years since the landmark FDA Amendments Act that followed. As those anniversaries approached, IoM convened a workshop for an update on the changes at FDA since FDAAA. Here's what we heard.
FDA's Selective Response to the IoM Drug Safety Report
FDA says its plan to improve the post-marketing drug safety system embraces most of the recommendations made by the Institute of Medicine in a 2006 report. But in several respects, the agency's response isn't exactly what IoM had in mind.