Pharma & Drug Safety

Instinct Plus Endoscopic Clipping Device Recalled Due to Malfunctions

Health Canada has issued a Type II recall for the Instinct® Plus Endoscopic Clipping Device manufactured by Wilson-Cook Medical, Inc. due to malfunctions where the clip may remain attached to the drive wire and cannot be opened. This recall affects products manufactured prior to corrective actions being implemented.

Monoject Syringe Recall - Incorrect Insulin Labeling

Health Canada has issued a recall for Monoject 1mL Luer Lock Syringes due to incorrect insulin labeling. The outer packaging indicates a tuberculin syringe, but the syringes inside are U-100 insulin syringes. Healthcare providers are advised to contact the manufacturer for more information.

SOLTIVE Laser System Recall

Health Canada has issued a Type II recall for the SOLTIVE Premium SuperPulsed Laser System due to a defect in the 24V power supply causing sudden power loss. Affected healthcare providers should contact the manufacturer for service coordination.

Arjo Tenor Mobile Lift Recall

Health Canada has issued a Type II recall for the Arjo Tenor Mobile Lift due to a defect in the brake component of the actuator. The defect can cause a loss of self-locking and uncontrolled descent, posing a safety risk. Affected units must be removed from use immediately.

FDA Launches Unified Adverse Event Analysis Platform AEMS

The FDA has launched a new unified platform, the Adverse Event Monitoring System (AEMS), to analyze adverse event reports for all regulated products. This modernization aims to improve data accessibility, transparency, and surveillance capabilities, replacing fragmented legacy systems and is expected to save $120 million over five years.

FDA Approves Wellcovorin for Cerebral Folate Deficiency

The FDA has approved Wellcovorin (leucovorin calcium) tablets for the treatment of cerebral folate deficiency in adult and pediatric patients with a confirmed FOLR1 gene variant. This marks the first FDA-approved treatment for this rare genetic condition.

FDA Streamlines Biosimilar Development Guidance

The FDA issued draft guidance to streamline biosimilar development by recommending the reduction of unnecessary clinical pharmacokinetic testing when scientifically justified. This initiative aims to save developers up to 50% in PK study costs, potentially lowering drug prices and increasing patient access to affordable biologic treatments.

FDA Meeting on State Drug Importation Program

The FDA held a meeting with several states to discuss the Section 804 Importation Program (SIP), which allows states to import certain prescription drugs from Canada. This meeting is part of the FDA's implementation of an executive order aimed at lowering drug prices for American consumers.

FDA Approves Tec-Dara for Relapsed Multiple Myeloma

The FDA has approved Tec-Dara (teclistamab and daratumumab hyaluronidase-fihj) for relapsed or refractory multiple myeloma. This approval was granted under the Commissioner's National Priority Voucher (CNPV) pilot program, marking a significant acceleration in the review process.

MHRA Guidance on Medicine Reclassification for Improved Access

The MHRA has published guidance discussing the potential benefits of reclassifying medicines to improve patient access to treatments and reduce pressure on NHS services. The guidance highlights opportunities for self-care and innovation within the consumer healthcare sector.