Ramsey Baghdadi
Latest From Ramsey Baghdadi
US Medicare Plans 'Can' Cover Wegovy, CMS Says, But Will They?
Medicare is making clear that Part D ‘can’ cover GLP-1 inhibitors that are approved for cardiovascular indications – but in language that seems to leave plans considerable discretion for now. The formulary review process for 2025 may be a more important milestone for changes.
An Artificial Intelligence Milestone For US FDA
A project to validate a depression severity measurement tool that employs artificial intelligence for use in drug trials is moving forward at FDA. The milestone is a sign of things to come – and of the incremental process for AI adoption by the regulator.
Advanced Manufacturing Technology Designation Guidance Uses Broad Criteria For ‘Novel’
In US FDA’s draft, mandated by in the current user fee legislation, contract manufacturers can also vie for a designation. CDER ETT and CBER CATT teams will play a key role in the process.
FDA Drug Development Meetings May Be Better Model For Future CMS Patient-Listening Sessions
The ability for Medicare officials to follow-up on patient testimony could make the sessions more informative. They also don’t all have to be the same.
Real-World Views On RWE: RECOVER Trial Seen As US Answer To UK’s RECOVERY
US FDA Commissioner Robert Califf held court with global regulators to discuss the overall state of real-world evidence and how different agencies across the world view it.
US FDA Office Of Immunology Turnover Tests Updated Review Structure
A leadership transition in FDA’s Office of Immunology & Inflammation will elevate former rheumatology division Director Nikolay Nikolov to the top spot – with a number of interim and inexperienced leaders in the management layers below.