The International Medical Device Regulators Forum (IMDRF) held a two-part workshop on September 11 and September…
Category: Regulatory Affairs
Global updates on medical device regulation and quality.
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…
FDA Expands Access to Treatment Addressing Neurological Challenges in Autism
Meta description: The FDA has initiated approval for leucovorin calcium tablets to assist patients with cerebral…
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…
IMDRF Digitalizes Membership Applications: New Online Platform Launches
Clinical, quality, and regulatory teams take note: Starting May 2025, the International Medical Device Regulators Forum…
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…
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…
Scemblix® Gains Extended Therapeutic Indication Approval from Swissmedic
Swissmedic has officially announced an extension of the therapeutic indications for Scemblix®, a drug that plays…
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…
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…