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AvaSure, Oracle And NVIDIA Launch Virtual Care Assistant For Enhanced Clinical Workflow (MedTech Insight)
HIMSS 2025: Google Cloud Launches Visual Q&A For Multimodal Search Capabilities (MedTech Insight)
Government, Regulatory & Legal
DTC Advertising: Industry Learning To Live With US FDA’s Clear, Conspicuous And Neutral Rule (Pink Sheet)
Health plans need to take accountability for a broken system (STAT)
NIH terminates ongoing grants for LGBTQ+ research (STAT)
Marty Makary, Trump nominee to lead FDA, pledges to avoid conflicts if confirmed (STAT)
Sutter Health settles sweeping antitrust case, narrowly avoiding trial (STAT)
UnitedHealthcare’s copay-only plan is booming, despite backlash over care denials (Endpoints)
NIH-backed research tries to use stem cells to restore the eye’s outer layer (Endpoints)
Wild Coast recalling raw cat food on bird flu contamination risk, FDA says (Reuters)
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.