The U.S. Food and Drug Administration (FDA) has announced a significant development in regulatory initiatives. On…
Category: US
US / FDA updates on medical device regulation and quality.
FDA Warns of Serious Risks Linked to Radiofrequency Microneedling Devices for Aesthetic Skin Procedures
The U.S. Food and Drug Administration (FDA) has issued a safety communication concerning serious complications associated…
FDA Issues Boxed Warning Update for CARVYKTI Over Rare Enterocolitis Risk
The U.S. Food and Drug Administration (FDA) has issued updated labeling for Ciltacabtagene Autoleucel (CARVYKTI), a…
Urgent FDA Alert: Cybersecurity Vulnerability Identified in Abiomed’s Automated Impella Controller
On October 10, 2025, the FDA issued an alert regarding a cybersecurity vulnerability affecting the Automated…
Trividia Health Initiates Precautionary Recall of Certain TRUE METRIX Blood Glucose Meters Due to Display Issue
Trividia Health, Inc., a leading global health and wellness company, has initiated a voluntary recall of…
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…
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,…
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…
FDA Introduces Daily Updates on Adverse Event Reporting for Drug Safety Insights
The U.S. Food and Drug Administration (FDA) has announced a major step forward in public health…
FDA Demands Safer Nicotine Pouch Packaging Amid Rising Cases of Child Exposure
The U.S. Food and Drug Administration (FDA) has issued a strong appeal to nicotine pouch manufacturers,…