Crescent Pharma Limited has reported a significant issue related to one of its distributed products, Simvastatin…
Category: Regulatory Affairs
Global updates on medical device regulation and quality.
Zaditen Eye Drops Recall Announced Over Microbial Contamination Risks
In a recent update concerning pharmaceutical safety, Thea Pharmaceuticals Limited (trading as Laboratoires Théa) initiated a…
Critical Updates: Field Safety Notices Released for 30 June to 4 July 2025
Healthcare professionals specializing in clinical, quality, and regulatory affairs should note the latest developments regarding medical…
Critical Updates: Field Safety Notices Published for Medical Devices (7–11 July 2025)
Healthcare professionals and teams responsible for compliance and patient safety should take note of the latest…
FDA Urges Retailers to Cease Illegal Vape Sales in New Compliance Initiative
Marty Makary, M.D., M.P.H., Commissioner of the U.S. Food and Drug Administration (FDA), has announced a…
Latest Field Safety Notices Highlight Critical Updates for Medical Devices: 14–18 July 2025
Medical device professionals should be aware of the latest Field Safety Notices (FSNs) published between 14…
FDA Greenlights First Drug Targeting New World Screwworm in Cattle, Offering Prevention and Treatment
The U.S. Food and Drug Administration (FDA) has granted conditional approval for Dectomax-CA1 (doramectin injection), marking…
Critical Update: Positive Bias Detected in Trinity Biotech Premier Hb9210™ HbA1c Analyser Results
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued an alert regarding the Trinity…
Updated Safety Alert: Flutiform 250/10 mcg Inhalation Recall Due to Packaging Error
On September 30, 2025, the Medicines and Healthcare products Regulatory Agency (MHRA) announced a Class 2…
Critical Update: Field Safety Notifications Released for Medical Devices (22–26 September 2025)
In a recent regulatory update crucial for healthcare professionals, the Medicines and Healthcare products Regulatory Agency…