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H5N1 bird flu virus particles found in pasteurized milk but FDA says commercial milk supply appears safe (STAT)
Profiting from ‘legal’ insider trading isn’t always easy (STAT)
Judge slashes $857 mln Monsanto verdict to $438 mln in PCBs case (Reuters)
Plaintiffs' lawyers chosen to lead Ozempic litigation (Reuters)
UBS faces new lawsuit by Appaloosa over Credit Suisse $17 bln bond wipeout (Reuters)
Insurer Humana pulls 2025 profit forecast on disappointing Medicare rates (Reuters)
Pharma Can Pursue Claims Against Providers For 340B Duplicate Discounts In Medicaid Managed Care, HRSA Says (Pink Sheet)
Mary Beth Clarke, CDER Exec Programs Office Director And Generic User Fee Shepherd, Will Retire (Pink Sheet)
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.