FDA sets FY 2027 medical device user fees, updating submission and registration costs under MDUFA V and outlining small business reductions.
Regulation
Two FCA consultation papers prepare for implementation of an equities CT in the UK and aim to improve accessibility and clarity of trade data.
Our in-brief roundup of notable stories from the last week.
A new study found proposed Medicare drug pricing models may rely on prices from relatively few international markets.
Overview of EU AI Act transparency obligations under Art 50, and guidance for legal and compliance counsel.
Case examines allegations involving AstraZeneca under the ABPI Code, underscoring the compliance controls drugmakers need to implement.
Centers for Medicare & Medicaid Services moves to strengthen oversight of Applied Behavior Analysis services and reduce fraud, waste, and abuse.
Analysing the compliance imperatives for both US pharma and the strategic considerations for Chinese biotech navigating the cross-border environment.