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Urgent Recall Alert for BD Alaris Infusion Sets

by MDP Staff | Jul 15, 2025 | Alerts, Alerts-Device, Class I Recalls, FDA Reports

BD Alaris Pump Module model 8100 Performance can worsen when connected to other perfusion sets Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact Class I Recall (Correction) The FDA has issued an...

Recall Alert: AirLife/Vyaire Infant Breathing Systems

by Bruce Waldon | Jul 10, 2025 | Alerts-Device, Class I Recalls, Med-Devices, MedWatch-System, Product Recalls, Products_Devices, Safety, US-FDA

AirLife/Vyaire Infant Breathing Systems Recall Potential for risk of disconnection Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact Class I Recall AirLife and manufacturer Vyaire are recalling...

Avanos Recalls Ballard Closed Suction Systems

by Bruce Waldon | Jul 10, 2025 | Alerts-Device, Class I Recalls, FDA Safety Communication, Industry News, Med-Devices, MedWatch-System, Product Recalls, US-FDA

Avanos Recalls Ballard Closed Suction Systems Due to sterilization failure Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact May result in non-sterile devices Avanos Medical, Inc. is recalling its...

The FDA Orphan Drug Program

by Bruce Waldon | Jul 9, 2025 | Consumer Information, FDA_Innovation, FDA_Programs, New Pharma Products, Orphan Drugs, Pharmaceuticals, Product-Innovation, US-FDA

FDA's Orphan Drugs Program Development of drugs for rare diseases Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact Incentives for Rare Disease Drug Development The FDA’s Orphan Drug Program was...

FDA Grants Accelerated Approval to Multiple Myeloma Treatment

by Bruce Waldon | Jul 9, 2025 | FDA Approvals, Industry News, New Drugs, New Pharma Products, Pharmaceuticals, Product-Innovation, US-FDA

FDA Grants Accelerated Approval to Lynozyfic A bispecific T-cell engager that targets BCMA on myeloma cells and CD3 on T-cells Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact For hard-to-treat...

FDA Approves Alhemo for Patients with Hemophilia A or B

by Bruce Waldon | Jul 8, 2025 | FDA Approvals, Industry News, New Drugs, New Pharma Products, Pharmaceuticals, US-FDA

FDA Approves Alhemo for Patients with Hemophilia Routine prophylaxis to prevent or reduce bleeding Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact For Patients with Hemophilia A or B with...
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