Regulatory Focus is the only source of timely, quality news and information fully dedicated to daily online coverage of the global regulation of healthcare products. An experienced team of reporters delivers all you need to know to stay current with the rapidly changing regulatory landscape in advancing public health. Mon, 13 Apr 2026 13:24:09 +0000 https://www.raps.org/news-insights/regulatory-focus.html https://fetchrss.com https://www.raps.org/news-insights/regulatory-focus.html https://www.google.com/s2/favicons?domain=https://www.raps.org dc0870ac4db13f2701dcaae8bf3fa539 https://www.raps.org/resource/this-week-at-fda-cnpv-vouchers-for-psychedelics-progress-on-animal-testing-reduction-and-more.html Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. The US Food and Drug Administration (FDA) made several announcements related to its new drug voucher program, highlighted efforts to reduce animal testing, and more.

]]> Fri, 24 Apr 2026 00:00:00 +0000 a25e9774127947d44f0dab75aea889e6 https://www.raps.org/resource/qmm-participants-scored-well-on-commitment-to-quality-lower-on-advanced-manufacturing.html Pharmaceutical companies participating in the US Food and Drug Administration (FDA) Quality Maturity Pilot (QMM) program generally received high scores for their commitment to quality and employee engagement, but scored lower in areas related to advanced pharmaceutical quality and technical excellence.

]]> Fri, 24 Apr 2026 00:00:00 +0000 c6d5df5155fdc3acc7f15d0bfa802b4d https://www.raps.org/resource/medcon-fda-official-offer-tips-on-verifying-validating-manufacturing-processes.html COLUMBUS, OH – It isn’t always clear when to choose to verify or validate manufacturing processes. But experts from the US Food and Drug Administration (FDA) recently offered some tips for helping to make sense of the decision.

]]> Fri, 24 Apr 2026 00:00:00 +0000 e2f3bf841507f0b1bf1a6ac41917d7f2 https://www.raps.org/resource/fda-cms-propose-new-parallel-review-pathway-for-breakthrough-devices.html The US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) have proposed a parallel review program to expedite certain Class II and Class III breakthrough medical devices to market for Medicare patients called the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway.

]]> Thu, 23 Apr 2026 00:00:00 +0000 b6abeaa2f14cc783c494813b239e621f https://www.raps.org/resource/mdcg-updates-guidance-on-device-classification-emdn-and-supply-disruptions.html The European Commission’s Medical Device Coordinating Group (MDCG) has revised several documents addressing the classification of products under the Medical Device Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR), as well as guidelines on borderline and classification, European Medical Device Nomenclature (EMDN), and handling supply interruptions and discontinuations.

]]> Thu, 23 Apr 2026 00:00:00 +0000 835386b6bde5748a91963bff179c0bc0 https://www.raps.org/resource/medcon-fda-sees-uptick-in-class-i-recalls-in-2025-as-it-tackles-resourcing-issues.html COLUMBUS, OH – The US Food and Drug Administration (FDA) saw more new recall events for class I medical devices in 2025 than it has in recent years, a trend that continues to trouble agency officials.

]]> Thu, 23 Apr 2026 00:00:00 +0000 f4e78d4faaba55607398d2a579da2c41 https://www.raps.org/resource/euro-roundup-ema-sees-slight-improvement-in-approval-submission-predictability-reversing-trend.html The trend for the timing of initial marketing authorization applications (MAAs) to be less predictable is slowly reversing but there remains room for improvement, the European Medicines Agency (EMA) said.

]]> Thu, 23 Apr 2026 00:00:00 +0000 b9ec34171a701537bd5c8d035ef6b157 https://www.raps.org/resource/recon-fda-approves-regeneron-s-hearing-loss-gene-therapy-novo-s-oral-diabetes-drug-reduced-blood-sugar-in-children-in-phase-3a-study.html Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

]]> Thu, 23 Apr 2026 00:00:00 +0000 f83727460709f7ebc5a3bae3febb1b33 https://www.raps.org/resource/ogd-director-touts-drop-in-refuse-to-receive-determinations.html The top generic drug regulator at the US Food and Drug Administration (FDA) on Wednesday touted the drop in refuse-to-receive (RTR) decisions his office issued for abbreviated new drug applications (ANDAs) in FY 2025 as a significant achievement for the agency.

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