Ramsey Baghdadi
Latest From Ramsey Baghdadi
FDA Neuroscience Director Dunn's Appearance At Tanezumab AdComm Confirms Neurology Office Is Intact
Dunn’s participation at the panel meeting ended speculation that he left the US FDA.
Will Pharma End Up Paying For The Infrastructure Bill?
Or can industry thread the donut hole and prevent government price negotiations from becoming a part of the legislative tsunami?
Medicare Coverage Policy Change Opens Up Commercial Market Pathway – If Biden Likes It
Modification to ‘reasonable and necessary’ definition in MCIT final rule offers new avenue for drug manufacturers to get products covered in Part B. The Biden Administration will have to decide whether it will keep the Trump regulation unchanged.
Flaws Of ‘Virtual’ Advisory Committees Highlighted At Aducanumab Panel
The intensely negative advisory committee for Biogen’s proposed Alzheimer’s therapy was a shocker. Would it have happened if US FDA had been able to convene an in-person event instead of a ‘virtual’ one?
The Greatest FDA Advisory Committees, Part III: The Power of The Patients
With landmark advisory committee meetings coming up, we take a look back at some of the memorable panel meetings over the last 20 years.
The Greatest FDA Advisory Committees, Part II: The Birth Of The ‘Pazdur Moment’
With landmark advisory committee meetings coming up, we take a look back at some of the memorable panel meetings over the last 20 years. This is Part II in the series.