Critical FDA Advisory: Updated Performance Alerts for BD Alaris Infusion Sets
An updated communication from the FDA highlights significant concerns regarding BD Alaris Infusion Sets’ performance under particular use conditions. Clinical, […]
Profemur Modular Neck Hip Implants: Heightened Risk of Fractures and Revision Surgery Identified
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued an important update regarding the risks associated with Profemur cobalt
IMDRF Digitalizes Membership Applications: New Online Platform Launches
Clinical, quality, and regulatory teams take note: Starting May 2025, the International Medical Device Regulators Forum (IMDRF) is transitioning its
FDA Reviews Risks: Acetaminophen in Pregnancy Linked to Autism Concerns
The FDA has announced a significant step in addressing emerging evidence regarding the use of acetaminophen (commonly known as Tylenol
Understanding Medical Device Recalls: What Healthcare Professionals Need to Know
Medical device recalls are critical actions taken to address potential safety or regulatory violations associated with a device. Recently, updates
Scemblix® Gains Extended Therapeutic Indication Approval from Swissmedic
Swissmedic has officially announced an extension of the therapeutic indications for Scemblix®, a drug that plays a pivotal role in
Regulatory Alert: Patient Information Leaflet Defect for Hikma Farmacêutica’s Gemcitabine 2g/52.6ml Infusion Concentrate
On September 30, 2025, Hikma Farmacêutica (Portugal) S.A issued a notification to the Medicines and Healthcare products Regulatory Agency (MHRA)
Critical FDA Update: BD Expands Class I Recall for Alaris™ Pump Infusion Sets
Meta Description: BD has expanded its voluntary Class I recall for Alaris™ Pump infusion sets, adding 15 discontinued models with
FDA Lifts REMS for Caprelsa (vandetanib), Signaling New Safety Confidence
The U.S. Food and Drug Administration (FDA) has announced the removal of Risk Evaluation and Mitigation Strategies (REMS) for Caprelsa
Regulatory Update: Swissmedic Confirms Safety of Paracetamol Use During Pregnancy
Swissmedic, Switzerland’s regulatory authority for therapeutic products, has reaffirmed its position on the use of medicines containing paracetamol during pregnancy.