REMS Vendor Disruptions Prompt Greater US FDA Scrutiny
Executive Summary
McKesson’s exit from the space forced sponsors to switch vendors managing their REMS programs, which in some instances affected patient access to drugs. Omnibus legislation requires GAO report and collection of public input on factors FDA should consider in reviewing vendor changes.
You may also be interested in...
Switching REMS Vendors: AAM Calls For FDA Guidance On Performance Standards
The trade association says it is impractical for a sponsor or REMS administrator to conduct a ‘failure modes and effects analysis’ to plan for system failures while United BioSource and the National Council for Prescription Drug Programs supports the testing.
Switching REMS Vendors: AAM Calls For FDA Guidance On Performance Standards
The trade association says it is impractical for a sponsor or REMS administrator to conduct a ‘failure modes and effects analysis’ to plan for system failures while United BioSource and the National Council for Prescription Drug Programs supports the testing.
iPLEDGE REMS: FDA Panel To Consider Changing Pregnancy Testing, Counseling Requirements
Advisory committee to discuss proposed changes to isotretinoin REMS to minimize burden and treatment delays while preventing risk of fetal exposure. Agency recommends against at-home pregnancy tests.