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Why Trump’s former surgeon general wants Kennedy removed: ‘an absolute failure of leadership’ (STAT)
Inside the hospital ‘war rooms’ bracing for Medicaid cuts (STAT)
HHS to have Rensselaer investigate question of autism-vaccine link (STAT)
Over half of US healthcare workers plan to switch jobs by next year, survey finds (Reuters)
FTC’s New Healthcare Division Chief Is Former Antitrust Prosecutor (MedTech Insight)
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.