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Laura Helbling

Laura Helbling is Director of Research at Prevision Policy and a Senior Writer at The RPM Report (now Pink Sheet). Laura has a degree in magazine journalism from the University of Missouri School of Journalism.
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Latest From Laura Helbling

More US FDA Departures: ODE II Director Rosebraugh, GI Division Director Griebel to Retire

FDA will have three leadership positions vacant in the Office of Drug Evaluation II when Curtis Rosebraugh leaves at the end of the month. 
FDA Leadership

It's NTAP Season!

In a Pink Sheet podcast, Prevision Policy analysts discuss the US Medicare program's new technology add-on payment process.

 

Medicare Reimbursement

US FDA Pushes Back On Proposal For Early Clinical Designations To Support Higher Reimbursement Decisions

Breakthrough, RMAT designations signal clinical potential and are not intended to have reimbursement impact after approval, FDA says. 
Review Pathway Reimbursement

Reimbursement Challenge: CMS Questions Azedra Endpoint While Still Under FDA Review

Progenics' radiopharmaceutical using novel surrogate endpoint for US FDA review; CMS seems unimpressed, which doesn't bode well for new technology add-on payment.
Rare Diseases Neurology

Liposomal Drugs Should Not Be Compounded – Until Technology Catches Up

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.

Advisory Committees Manufacturing

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.

Drug Review Metabolic Disorders
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