A review of drugs and supplemental uses since the project’s inception shows roughly one-third of the products reviewed have been NMEs.

Five sponsors withdrew their applications for new technology add-on payments from CMS – all due to regulatory reasons happening at the US FDA.

Dunn’s participation at the panel meeting ended speculation that he left the US FDA.

Or can industry thread the donut hole and prevent government price negotiations from becoming a part of the legislative tsunami?

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.

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?