Industry News
The latest medical device regulatory news, clinical trials, and market insights
MHRA’s Latest Safety Guidance: Key Updates for Medical and Device Users – June 2025 Edition
The Medicines and Healthcare products Regulatory Agency (MHRA) has released the latest safety guidance for medication and medical device users…
Swissmedic Introduces Horizon Scanning Platform to Enhance Regulatory Oversight
Swissmedic has unveiled a new horizon scanning website to improve proactive regulatory measures. This initiative aims to streamline the identification…
IMDRF Working Group Updates Open for Feedback: Key Regulatory Insights
The International Medical Device Regulators Forum (IMDRF) has announced the availability of updates from its Working Groups, which are set…
Critical Updates on Field Safety Notices Issued Between 16 to 20 June 2025
The UK Government has released a detailed summary of Field Safety Notices (FSNs) issued from 16 to 20 June 2025.…
Building Global Capacity for Medical Device Safety: IMDRF Workshop Insights
The International Medical Device Regulators Forum (IMDRF) held a pivotal two-part workshop on 11 and 19 September 2024. This initiative…
FDA Reacts to Florida’s Ban on 7-OH Opioid Products: What You Need to Know
Meta description: The FDA addresses Florida’s new restrictions on 7-OH opioid products, discussing implications for clinical and regulatory teams. Find…
Regulatory Alert: Recall of Kimmtrak 200 micrograms/mL Due to Potency Issues
Immunocore Limited is urgently recalling specific batches of its Kimmtrak 200 micrograms/mL concentrate for solution for infusion after stability testing…
IMDRF Launches Online Membership Forms: A Streamlined Submission Process
From May 2025, regulatory professionals and other stakeholders involved with medical device oversight will benefit from an important update. The…
FDA Greenlights Papzimeos: First Immunotherapy for Recurrent Respiratory Papillomatosis
On October 2, 2025, the U.S. Food and Drug Administration (FDA) announced the approval of Papzimeos, the first immunotherapy specifically…
Urgent Recall: Depo-Medrone Labeling Error Poses Dosage Risk
A recall has been issued for a batch of Depo-Medrone 80 mg in 2 mL vials due to a critical…
Breaking News: GHWP Withdraws Membership from IMDRF
On June 24, 2025, the Global Harmonization Working Party (GHWP) officially withdrew from the International Medical Device Regulators Forum (IMDRF),…
FDA Emergency Authorization of Animal Drugs Tackles New World Screwworm Threat to Food Supply
The U.S. Department of Health and Human Services (HHS) announced a declaration enabling the Food and Drug Administration (FDA) to…