US FDA Commissioner Robert Califf tells Congress that regulators don’t have to know how artificial intelligence works in medicine, but must make very sure it actually does work.

The US FDA has stood out as an agency that tends to draw broad bipartisan support amid a generally rancorous and divided Congress. A House hearing, however, may be a sign that those days are over.

Dramatic transformation in the US Medicare Part D benefit design does not require any changes to CMS’ overall approach to reviewing formulary submissions from private drug plan sponsors, the agency says in its final guidance implementing the design changes for 2025.

Bernie Sanders is back at it, getting headlines for demanding immediate price cuts to Novo’s blockbuster GLP-1 brands. But behind the familiar rhetoric is a newer threat: academic research on cost-based pricing that could one day feed into the emerging Medicare ‘negotiation’ system.

Latest update to draft guidance on early Alzheimer’s drug development is the third iteration of a document first published in 2013. The history of the guidance is a reflection of structural and leadership changes in the neurology review team at FDA.

President Biden’s call to expand the US Medicare price negotiation program is naturally making headlines from his campaign-year State of the Union Address. But his call for a national cap on co-pays could be an important opportunity for industry in the years to come.