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Boston Scientific Raises Outlook … Again: Headwinds Offset By EP And Watchman (MedTech Insight)
Food & Nutrition
Voluntary sustainable packaging goals are on the way out, Gartner says (Food Dive)
FDA looks to answer the question: What makes food ultra processed? (Food Dive)
Government, Regulatory & Legal
Researchers sequence complex parts of human genome, expanding the future of precision medicine (STAT)
Hospitals boost their profit expectations for 2025 as health insurers stumble (STAT)
The lessons New York still has not learned from the Covid vaccine rollout (STAT)
UnitedHealth investors may seek roadmap on costs as Hemsley takes center stage (Reuters)
Medical group urges Kennedy not to fire US care task force (Reuters)
Oyez, Oyez, Oyez! Effective August 1, DEA Will Have No Administrative Law Judges (FDA Law Blog)
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.