FDA’s Sentinel network
This article was originally published in The Gray Sheet
Executive Summary
FDA and the Department of Defense announce a memorandum of understanding Aug. 2 to share data and expertise to spot trends and monitor the safety of regulated devices, drugs and biologics. DoD will provide general patient data from programs including the military's Tricare health plan. The agreement is part of FDA's proposed Sentinel network, an initiative announced in January to explore linking public and private sector information to create an integrated postmarket data network (1"The Gray Sheet" March 12, 2007, p. 15)...
You may also be interested in...
FDA Hears Experience Of Regional Device Safety Registries
FDA is soliciting ideas from regional programs that gather postmarket data to help design its proposed "Sentinel Network" for medical product safety information
Partisan Politics Returns To US FDA Congressional Oversight
The US FDA has stood out as an agency that tends to draw broad bipartisan support amid a generally rancorous and divided Congress. A House hearing, however, may be a sign that those days are over.
GLP-1 Coverage Restrictions In Medicare Part D Surge As Demand For Obesity Drugs Grows
A major shift from unfettered coverage to prior authorizations was recorded by MMIT over the past year for the leading GLP-1/GIP agonist diabetes drugs. Public interest in using the drugs off label for weight loss drove the change.