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Federal officials step down from health AI group’s board (MedTech Dive)
Endoron Staples Down $10M To ‘Revolutionize’ Abdominal Aortic Aneurysm Repair (MedTech Insight)
Sinaptica’s Breakthrough Device Could Slow Brain Atrophy In Alzheimer’s Patients – Study (MedTech Insight)
Orange Book Is The New Spat: FTC Seeks Removal Of ‘Improperly’ Listed Medical Device Patents (MedTech Insight)
Government, Regulatory & Legal
Sanford Health aims to shake off a run of failed deals by snapping up a $3 billion Wisconsin health system (STAT)
Medicaid is paying millions for salty, fat-laden ‘medically tailored’ cheeseburgers and sandwiches (STAT)
Doctors ‘overprescribing’ opioids isn’t the cause of the overdose epidemic — and it never was (STAT)
Preparing schools for the H5N1 bird flu they’re likely to face (STAT)
US FDA’s Genetic Metabolic Diseases Adcomm Debuts With Zevra’s Arimoclomol (Pink Sheet)
Power to the Patient with Patient Generated Health Data (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.