Regulatory Affairs

FDA Strengthens Recall Processes After Infant Botulism Cases Linked to ByHeart Formula

The U.S. Food and Drug Administration (FDA) has announced plans to enhance the effectiveness of food recalls. This comes after…

FDA Seeks Venture Capital Input to Reform Contracting for Public Health Innovation

The U.S. Food and Drug Administration (FDA) is exploring new avenues for collaboration with America’s top innovators to advance public…

FDA Recognizes Two Investigational Products with National Priority Vouchers for Affordability Breakthroughs

On January 12, 2026, the U.S. Food and Drug Administration (FDA) announced a significant milestone in regulatory advancements by awarding…

FDA Report Highlights Data Gaps Regarding PFAS Safety in Cosmetics

The U.S. Food and Drug Administration (FDA) has released a congressionally mandated report on the safety of perfluoroalkyl and polyfluoroalkyl…

FDA Eases Oversight for Cell and Gene Therapies, Encouraging Innovation

The U.S. Food and Drug Administration (FDA) has announced updates to its approach for evaluating chemistry, manufacturing, and control (CMC)…

Europe

December 2025 MHRA Safety Updates: New Guidance for Medicine and Medical Device Users

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued its December 2025 roundup of the latest safety updates for…

Europe

Critical Updates: Field Safety Notices from December 22–26, 2025

The latest Field Safety Notices (FSNs) issued between December 22 and December 26, 2025, are now available. These updates are…

Europe

Critical Updates: Field Safety Notices Published Between 29 December 2025 and 2 January 2026

The UK Health Authorities have released an updated list of Field Safety Notices (FSNs) covering the period from 29 December…

Critical Update: Safety Correction Issued for Siemens Healthineers 3 Tesla MRI Systems

On January 11, 2026, the FDA published an urgent alert regarding a correction by Siemens Healthineers for certain 3 Tesla…

FDA Early Alert: Safety Risks Identified in Integra LifeSciences Convenience Kits

The U.S. Food and Drug Administration (FDA) issued an early alert regarding safety concerns with specific lots of Integra LifeSciences…

FDA Urges Immediate Recall of Draeger ErgoStar Catheter Mounts Over Safety Risks

The FDA has issued a critical announcement regarding the recall of certain Draeger ErgoStar Catheter Mounts. This action pertains to…

IMPRIS Imaging Issues Urgent Medical Device Correction for IMRIS Neuro III-SV Over Safety Risks

On October 13, 2025, IMPRIS Imaging Inc. initiated an urgent correction notice for its IMRIS Neuro III-SV models in response…