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Trump administration launches health data sharing initiative (MedTech Dive)
GE HealthCare projects reduced tariff expense (MedTech Dive)
Biostate AI Builds Global RNA-AI Pipeline With $12M Boost, Ventures In China And India (MedTech Insight)
Food & Nutrition
Trump’s Brazil Tariffs Upend Crop Prices From Coffee to Juice (Bloomberg)
Chobani sued by Danone for allegedly copying cold brew packaging (Food Dive)
Government, Regulatory & Legal
Top White House pandemic preparedness official resigns, officials say, in sign of broader disarray (STAT)
Researchers sequence complex parts of human genome, expanding the future of precision medicine (STAT)
Warren questions HHS general counsel nominee about vaccines, abortion (The Hill)
Cooper’s North Carolina Senate bid will put Medicaid front and center (The Hill)
The Vaccine Injury Compensation Program needs to be updated, not eliminated (STAT)
A Tip of the Hat to Retiring DEA Chief ALJ Mulrooney (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.