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Neuralink rival Synchron takes stake in medical component maker Acquandas (Reuters)
FDA extends deadline for comments on role of digital health in diabetes detection (MedTech Dive)
Government, Regulatory & Legal
General Catalyst wants to take over a safety-net health system in Akron. The city has questions (STAT)
Why I left the editorial board of the prestigious scientific journal NeuroImage — and helped start something new (STAT)
Lawsuit accuses UPenn and Jim Wilson of secretly profiting from former postdoc's work (Endpoints)
GSK inks another Zantac settlement ahead of trial in California (Fierce Pharma)
FDA slams Eugia with Form 483 and posts older reprimands for AGC, Baxter (Fierce Pharma)
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.