Casgevy Gene Therapy Expanded to 2-Year-Old Children

by Devices and Pharma | Jul 16, 2026 | FDA Public Information, FDA_Innovation, Gene Therapy, Gene Therapy, Industry Information, Industry News, Products_biologics

Home About Consumer News Food and Beverage Supplements Cosmetics Regulatory Medical Devices Pharma Biologics Combination Products In Vitro Diagnostics Veterinary AI Quality QMSR Central News Enforcement Alerts Innovation Contact FDA Expands Casgevy Gene Therapy...

FDA Warns Amazon for Unapproved Drugs Sold On Its Website

by Devices and Pharma | Jun 24, 2026 | Consumer Information, Drug Warning Letters, FDA Public Information, Industry Information, Industry News, Pharmaceutical Labeling, Products_Drugs, Unapproved Drugs, US-FDA

FDA Warning Letters Unapproved drugs marketed on Amazon.com website Home About Consumer News Food and Beverage Supplements Cosmetics Regulatory Medical Devices Pharma Biologics Combination Products In Vitro Diagnostics Veterinary AI Quality QMSR Central News...

Infant Formula Recalled after Reports of Botulism

by Devices and Pharma | Jun 16, 2026 | Alerts - Food, Consumer Information, FDA Public Information, FDA Safety Communication, Industry News, MedWatch-System, Products - Food, Recalls, Safety, US-FDA

Product Safety Recall Nara Organics Powdered Infant Formula Home About Consumer News Food and Beverage Supplements Cosmetics Regulatory Medical Devices Pharma Biologics Combination Products In Vitro Diagnostics Veterinary AI Quality QMSR Central News Enforcement...

FDA Clears First OTC Continuous Glucose Monitor for Children

by Devices and Pharma | Jun 12, 2026 | Consumer Information, FDA Approvals, FDA Public Information, Industry Information, Industry News, Med-Devices, New devices, Products_Devices, US-FDA

Medical Device Innovation First over-the-counter continuous glucose monitor for children Home About Consumer News Food and Beverage Supplements Cosmetics Regulatory Medical Devices Pharma Biologics Combination Products In Vitro Diagnostics Veterinary AI Quality QMSR...

April 2026 Update for FDA QMSR Inspection Results

by Devices and Pharma | Apr 23, 2026 | Analytics, FDA Public Information, FOIA, Industry Information, Industry News, Inspections, Inspections, Med-Devices, Products_Devices, QMSR, Quality system, US-FDA

Home About Consumer News Food and Beverage Supplements Cosmetics Regulatory Medical Devices Pharma Biologics Combination Products In Vitro Diagnostics Veterinary AI Quality QMSR Central News Enforcement Alerts Innovation Contact April 2026 Update for FDA QMSR...

FDA Class I Recall for Abiomed Impella Gen 1 Purge Cassettes

by Bruce Waldon | Apr 6, 2026 | Alerts, Alerts-Device, Class I Recalls, FDA Public Information, MedWatch-System, Product Recalls, Products_Devices, Reg_Products, Safety, US-FDA

FDA Class I Recall Abiomed Impella heart pumps cassettes Home About Consumer News Food and Beverage Supplements Regulatory Medical Devices Pharma Biologics Combination Products Veterinary AI Quality QMSR Central News Enforcement Alerts Innovation Contact Medical...