FDA Approves Lamzede for Treatment of Alpha-mannosidosis

by David McConkey | Mar 19, 2023 | FDA Approvals, FDA Public Information, Industry News, New Drugs, New Pharma Products, Pharmaceuticals, Product-Innovation, US-FDA

Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact The U.S. Food and Drug Administration (FDA) on February 17, 2023 announced the approval the first-ever enzyme...

FDA Warning Letter to Olympus Medical Systems

by Devices and Pharma | Mar 19, 2023 | FDA Enforcement, FDA Warning letters, Med-Devices, US-FDA

Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact Letter addresses several violations of FDA&C Act On March 15, 2023, the Food and Drug Administration (FDA)...

Class I Recall for Intra-Aortic Blood Pumps

by Devices and Pharma | Mar 18, 2023 | Alerts, Alerts-Device, Class I Recalls, Consumer Safety, Industry News, Med-Devices, Product Recalls, Product Safety, US-FDA

Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact Datascope/Getinge IABPs May Malfunction Due to Cable Failure The US Food and Drug Administration (FDA) announced...

Urgent Action Required – Baxter LIFE2000 System

by Devices and Pharma | Mar 17, 2023 | Alerts, Alerts-Device, Class I Recalls, Consumer Safety, Med-Devices, Product Recalls, Product Safety, US-FDA

Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact Software issue can cause potential harm or death On March 10, the US Food and Drug Administration (FDA) announced...

FDA Approves Rukabia for HIV Treatment

by David McConkey | Mar 16, 2023 | FDA Approvals, FDA Public Information, Industry News, New Drugs, New Pharma Products, Pharmaceuticals, Product-Innovation, US-FDA

Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact The U.S. Food and Drug Administration (FDA) on December 22, 2022 announced the approval of a new HIV drug called...

FDA Warning Letter to Jackson Clinic

by Devices and Pharma | Mar 12, 2023 | Consumer Information, FDA Enforcement, FDA Warning letters, Industry News, Pharmaceuticals, US-FDA

Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact Warning Letter Sites Violations of Law  In early February of this year, the U.S. Food and Drug Administration (FDA)...