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Biden administration wants to rein in use of AI in Medicare Advantage, among other fixes (STAT)
Embecta discontinues insulin patch pump development (MedTech Dive)
Zimmer wins FDA approval for cementless partial knee implant (MedTech Dive)
Government, Regulatory & Legal
Government watchdog calls out HHS for not auditing health care’s privacy compliance since 2017 (STAT)
Inside the telehealth-fueled GLP-1 alternative market (STAT)
UnitedHealth pays its own physician groups considerably more than others, driving up consumer costs and its profits (STAT)
Getting into the weeds on marijuana excise taxes: trends and outliers in the largest markets (Reuters)
New EU Fee Regulation: Smaller Firms & Orphan Drugs Will Still Benefit From Full Reductions (Pink Sheet)
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
Three major pharmaceutical industry groups—two in the US and one in India—have called for changes to the US Food and Drug Administration's (FDA) Scale-Up and Post-Approval Changes (SUPAC) guidelines. They believe these guidelines should be updated to reflect more modern manufacturing methods and better align with International Council for Harmonisation (ICH) standards.
Patients with breast cancer said faster approval times for oncology products, as a trade-off for evidentiary certainty, is most permissible in situations where there are no treatment alternatives, the results from a recent qualitative study suggest.