FDA Approval for Cancer Treatment Aid

by David McConkey | Mar 8, 2023 | Consumer Information, FDA Approvals, FDA Public Information, Industry News, Med-Devices, New devices, Product-Innovation, US-FDA

Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact The Food and Drug Administration (FDA) on 12 December 2022 announced the approval of Agilent’s Resolution CTDX...

FDA Accelerated Approval for Alzheimer’s Disease Treatment 

by David McConkey | Mar 6, 2023 | Consumer Information, 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 US Food and Drug Administration (FDA) announced on 06 January, 2023 that it had granted accelerated approval for...

FDA Posts Warning Letter to MicroVention Costa Rica 

by Devices and Pharma | Mar 1, 2023 | Alerts, FDA Enforcement, FDA Warning letters, Industry News, Med-Devices, US-FDA

Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact Identifies several violations of the FD&C Act and QSR  On February 7, FDA issued a warning letter it had sent to...

FDA Issues Letter to Warn of Abbott Trifecta Valve Risks 

by Devices and Pharma | Mar 1, 2023 | Alerts, Consumer Safety, FDA Public Information, Industry News, Med-Devices, Product Safety, US-FDA

Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact Letter outlines risks associated with the heart valve  On February 27, the FDA released a letter to healthcare...

FDA Announces Recall of GE Nuclear Medicine Systems 

by Devices and Pharma | Feb 26, 2023 | Alerts, Alerts-Device, Class I Recalls, Consumer Safety, Industry News, Med-Devices, MedWatch-System, 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 1200-pound Devices Could Fall on Patients On February 15, the FDA issued a statement announcing a recall of certain...

FDA announces recall of LivaNova LifeSPARC System 

by Devices and Pharma | Feb 12, 2023 | Alerts, Alerts-Device, Class I Recalls, Med-Devices, MedWatch-System, Product Recalls, US-FDA

FDA Announces Recall of LivaNova LifeSPARC System Home About Consumer Medical Devices New Devices Safety Alerts Warning Letters Pharma New Drug Approvals Drug Shortages Safety Alerts Warning Letters Regulatory Services 510(k) Submissions Documentation News Enforcement...