Part D’s Six Protected Drug Classes May Ride Baucus Medicare Vehicle

A statutory requirement that Medicare Part D drug plans cover "all or substantially all" drugs in six classes stands a good chance of making it into the Senate Finance Committee's upcoming Medicare physician payment package

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US FDA Finds ‘Significant’ Data Integrity Breaches In CRO Raptim Studies

 

The US FDA has deemed certain in vitro bioequivalence studies conducted by CRO Raptim Research “not acceptable” and raised concerns over its in vivo study methods.

US Pharma Tariff Reprieve May Be Ending

 

Sector-specific tariffs, including on pharmaceuticals, could be announced as early as this week.

Missing BsUFA Revenue Trigger Could Open US FDA Staff To Criminal Penalty

 

Massive layoffs and the biosimilar user fee program’s historic flirtation with the non-user fee spending requirements raise concerns that the FDA could lose its ability to collect BsUFA revenue, which could mean a fine or jail time for agency staff.