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Latest From Laura Helbling
In a Pink Sheet podcast, Prevision Policy analysts discuss the US Medicare program's new technology add-on payment process.
US FDA Pushes Back On Proposal For Early Clinical Designations To Support Higher Reimbursement Decisions
US FDA’s Pharmacy Compounding Advisory Committee agrees with AbbVie that liposomal drugs and products using hot melt extrusion should be listed as prohibited from compounding – but the panel also hopes to see technology advance to change that conclusion.
FDA Endocrinology Division To Be Led By Thanh Hai On Interim Basis; Guettier Leaving For Private Sector
Mary Thanh Hai ran the US agency's division for seven years before moving up in 2013; Guettier’s departure may provide an opportunity for CDER Director Woodcock to start to implement her vision for changes in the Office of New Drugs.