RAPS Learning Portal will be under maintenance on 12 June 2026 between 10 PM - 12 AM ET. Learning Portal functionality and profile access may be unavailable during this window.
We apologize for any inconvenience caused during this time.
Zimmer licenses NeuroOne brain ablation system (MedTech Dive)
Government, Regulatory & Legal
These 7 watchdogs scour scientific papers for problems — and often find them (STAT)
Key senators propose using ‘site-neutral’ pay to boost rural hospitals (STAT)
BMS, J&J and AstraZeneca plea with appeals court to overturn drug price negotiations (Endpoints)
US FDA’s New Rare Disease Hub Director Rick Brings Advocacy Experience (Pink Sheet)
Practical Matters: Rare Disease Advocates Want Help From US FDA Hub To Make Data Useful (Pink Sheet)
As Jurisprudence Under Loper Bright Develops, Early Scorecard is Mixed (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.