RAPS

MDCG outlines postmarket surveillance expectations under MDR/IVDR

The European Commission@s Medical Device Coordination Group (MDCG) has outlined the postmarket surveillance (PMS) requirements that medical device and in vitro diagnostic makers should adhere to as ...
RAPS

Recon: Amgen to acquire Dark Blue for 480M CDC slashes recommendations for childhood vaccines

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
RAPS

FDA posts warning letters to manufacturers of breast binders

The US Food and Drug Administration (FDA) on Thursday issued warning letters to 12 manufacturers and retailers for illegally marketing breast binders to children for gender-affirming surgery. The ...
RAPS

EU Commission proposes major reforms to MDR

The European Commission has proposed targeted reforms aimed at simplifying rules for medical devices. The proposed reforms are part of a package of measures put forth by the Commission this week to ...
RAPS

FDA loosens restrictions on using patient-level RWD in medical device submissions

The US Food and Drug Administration (FDA) clarified in a final guidance dated 17 December that it will accept real-world evidence (RWE) without requiring identifiable patient-level data in medical ...
RAPS

This Week: FDA staff raise alarm over CNVP, no COVID-19 vaccine boxed warning, and more

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. This week, FDA ...
RAPS

FDA finalizes safety reporting guidances for sponsors and investigators

The US Food and Drug Administration (FDA) has finalized two guidances for sponsors and investigators regarding adverse event reporting for drugs, biologics, and medical devices in clinical studies.
RAPS

Regulatory Intelligence 101, Third Edition

The third edition of Regulatory Intelligence 101 was developed for all regulatory professionals who generate regulatory intelligence, particularly those who deliver this key service to others in their ...
RAPS

Asia-Pacific Roundup: New Zealand’s Medsafe finalizes bioequivalence guidelines

The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has finalized its revised guidance on running studies to show products are bioequivalent.
RAPS

DIA 2026 Global Annual Meeting

Join us June 14-18, 2026 in Philadelphia, PA Join global leaders, innovators, regulators, academics, and patient advocates in Philadelphia, PA for the DIA 2026 Global Annual Meeting. As the life ...
RAPS

Potential to performance: How regulatory organizations are adopting AI

This article reports the findings from a 2025 benchmarking survey on the adoption of regulatory artificial intelligence (regulatory AI) across pharmaceutical and life sciences industries to learn how ...