FDA Drug Safety Reforms Not Enough To Fix Problems, IoM Committee Says
Executive Summary
A separate postmarketing safety center may become necessary if the recommendations made by the Institute of Medicine's Committee on the Assessment of the U.S. Drug Safety System do not result in sufficient reforms of FDA's safety oversight, the committee says
You may also be interested in...
Rx Safety: FDA Needs Deadline - Not Funding - To Improve Process, GAO Says
GAO is not buying an FDA assertion that the delay in giving the Office of Surveillance and Epidemiology more responsibility for post-market drug safety decisions is a funding issue
Rx Safety: FDA Needs Deadline - Not Funding - To Improve Process, GAO Says
GAO is not buying an FDA assertion that the delay in giving the Office of Surveillance and Epidemiology more responsibility for post-market drug safety decisions is a funding issue
FDA’s Sentinel Program Readies For Patrol As Stakeholders Watch For Details
HHS unveiled the first phase of FDA's "Sentinel" post-market drug safety surveillance initiative with fanfare May 22, but stakeholders will have to wait a while for details on funding and the timing of a full-scale rollout