FDA Introduces Groundbreaking Guidance to Streamline Rare Disease Drug Development
The U.S. Food and Drug Administration (FDA) has launched the Rare Disease Evidence Principles (RDEP) initiative, promising faster and more…
Regulatory Affairs
Global updates on medical device regulation and quality.
441 articles
441 articles in Regulatory Affairs
Latest News
Europe
Critical Advisory: New Aurum 10ml CONNECT Syringe Barrel Requires Compatible Needle-Free Connectors to Prevent Blockages
Healthcare professionals are urged to adopt compatible needle-free connectors (NFCs) with the newly phased-in Aurum 10ml CONNECT syringe barrels. This…
Europe
Critical Update: Barcode Error Identified in Simvastatin 10mg From Crescent Pharma
Crescent Pharma Limited has reported a significant issue related to one of its distributed products, Simvastatin 10mg Tablets, in the…
Europe
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 Class 2 Medicines Recall…
Europe
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 device safety. A comprehensive…
Europe
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 Field Safety Notices (FSNs)…
Latest News
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 pivotal step in addressing…
Europe
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 July and 18 July…
Latest News
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 a significant milestone for…
Europe
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 Biotech Premier Hb9210™ HbA1c…
Europe
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 medicines recall involving specific…
Europe
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 (MHRA) published Field Safety…
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