by Devices and Pharma | May 3, 2024 | Alerts, Alerts-Pharma, Consumer Information, Consumer Safety, FDA Safety Communication, Industry News, Pharmaceuticals, US-FDA
FDA Health Alert Regarding Rare Pregnancy Complication Risk of intrahepatic cholestasis of pregnancy (ICP) Home About Consumer Medical Devices Pharma AI Regulatory Quality News Enforcement Alerts Innovation Contact FDA Safety Communication In a recent health safety...
by Devices and Pharma | Apr 30, 2024 | Alerts, Alerts-Device, Class I Recalls, Industry News, Med-Devices, Pharmaceuticals, Product Recalls
Recall Notice for BioMérieux VITEK 2 AST Kit An anomaly in Ceftriaxone concentrations results in misreading bacterial susceptibility Home About Consumer Medical Devices Pharma AI Regulatory Quality News Enforcement Alerts Innovation Contact Class I Recall Notice ...
by Devices and Pharma | Apr 30, 2024 | Consumer Information, Global-RA, Industry Information, Pharmaceuticals, Product Quality, Product-Innovation, Quality Information, Reg_Information, The ICH
Exploring the Role of ICH in Global Pharmaceutical Standards The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) plays a pivotal role in shaping global pharmaceutical practices, ensuring the quality, safety,...
by Devices and Pharma | Apr 21, 2024 | Global-RA, Industry Information, Med-Devices, Pharmaceuticals, Reg_Information, Reg_Science
Regulatory Information Management Systems (RIMS) Explained What Is a RIMS System? A Regulatory Information Management (RIM) system is a software solution designed to streamline and automate the management of regulatory information and processes within the life...
by Devices and Pharma | Apr 3, 2024 | FDA Approvals, Industry News, New Drugs, New Pharma Products, Pharmaceuticals, Product-Innovation, US-FDA
FDA Approves New Antibiotic for Three Different Uses Zevtera effective against three bacterial infections Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact FDA...
by Devices and Pharma | Apr 2, 2024 | Alerts, Alerts-Pharma, Consumer Information, Pharmaceuticals, Product Recalls
AvKARE Recalls Atovaquone Oral Suspension Potential Bacillus cereus contamination discovered during product testing Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact...
