FDA Sentinel Transition Will Involve Expanding Rx Safety Data Sources
Executive Summary
Moving Mini-Sentinel pilot program to a fully operational and sustainable Sentinel postmarket safety surveillance system will take place over next year, CDER Director Woodcock says.
You may also be interested in...
FDA’s Sentinel Likely To Outpace Traditional Post-Market Studies, But Will It Replace Them?
Pilot project for overactive bladder drug Mybretriq raises questions as to how Sentinel will affect sponsor’s risk-monitoring obligations.
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.
Medicare Reimbursement For Part B Drugs Is 48% Above 340B Prices To Hospitals, MedPAC Finds
New study updates past commission analyses and highlights the significant margin between Medicare payments for drugs and the prices paid by 340B-eligible providers.