by Devices and Pharma | Mar 25, 2023 | Industry News, Med-Devices, New devices, Product-Innovation, Reg_Information, US-FDA
A Team-Based Approach to an Expedited 510(k) Working together for accelerated product introduction Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact Getting an...
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...
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...
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...
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)...
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...
