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With $40 million, former DeepMind employees launch startup ‘laser-focused’ on AI protein design (STAT)
GE HealthCare forecasts upbeat 2025 profit on steady medical device demand (Reuters)
Medtronic buys Nanovis’ nano technology for use in spine implants (MedTech Dive)
Judge orders FDA, health agencies to restore removed webpages (MedTech Dive)
Trump orders agencies to plan for ‘large-scale’ job cuts (MedTech Dive)
Edwards predicts second-half lift from TAVR label expansion (MedTech Dive)
Glucotrack Announces Successful First Human Clinical Study For Implanted CGM Device (MedTech Insight)
Government, Regulatory & Legal
People with alcohol-use disorder drank less on Ozempic, small study shows (STAT)
The FDA must remove an unnecessary barrier to the use of clozapine for treatment-resistant schizophrenia (STAT)
Young researchers mobilize to protest Trump administration’s science policies (STAT)
Medicare removes sexual orientation, gender identity questions from enrollment forms (STAT)
Nestle CEO defends packaged food ahead of Robert F. Kennedy Jr. confirmation (Reuters)
Into the Ashtray: FDA’s Previous Proposal to Ban Menthol Cigarettes (FDA Law Blog)
High medical costs have eaten away at CVS Health's earnings all year. There’s no quick fix (Endpoints)
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.