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UK says infant formula contamination could have affected 36 babies (Reuters)
Government, Regulatory & Legal
We helped create Medicare Advantage. Here’s how to fix it (STAT)
STAT Plus:Inside HHS’ anti-fraud efforts: An aggressive crackdown sweeps up mainly Democratic-led states (STAT)
FTC settles insulin suit with Express Scripts, with wider implications attached (Endpoints)
Genetic testing takes greater share of Medicare Part B test spending: OIG (MedTech Dive)
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.