by Bruce Waldon | Dec 18, 2025 | Alerts-Pharma, Analysis, Consumer Information, Consumer Safety, Editorial, FDA Policy, FDA Regulations, Hormones, Industry Information, Industry News, Product Safety, Products_Drugs, Regulatory_Info
Testosterone Regulation Takes a Sharp Turn Why FDA’s December panel raises red flags Home Request Info QMSR Central QMSR FAQs ISO 13485 Transition Impact Integration Definitions FDA and ISO 13485 ISO 9000 Small Manufacturers Why FDA’s December Panel Raises Red Flags...
by Devices and Pharma | Mar 14, 2025 | Alerts, Alerts-Pharma, Consumer Information, Consumer Safety, MedWatch-System, Products_Drugs
FDA Warning: Epinephrine Nasal Solutions Threat of packaging and labeling mixups Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact Left: BPI Labs’ FDA-approved Epinephrine Injection with blue lid...
by Devices and Pharma | May 18, 2024 | FDA Approvals, Industry Information, Industry News, New Drugs, New Pharma Products, Pharmaceuticals, Product-Innovation, Products_Drugs, US-FDA
FDA Grants Accelerated Approval to Tarlatamab-dlle Treatment for extensive stage small cell lung cancer Home About Consumer Medical Devices Pharma AI Regulatory Quality News Enforcement Alerts Innovation My Account Contact Treatment for lung cancer with progression...
by Devices and Pharma | May 7, 2024 | Consumer Information, FDA Approvals, FDA_Innovation, Industry News, New Drugs, New Pharma Products, Pharmaceuticals, Product-Innovation, Products_Drugs, Reg_Products, US-FDA
FDA Approves New Imaging Drug LumiSight Enhances cancer detection in breast lumpectomy procedures Home About Consumer Medical Devices Pharma AI Regulatory Quality News Enforcement Alerts Innovation My Account Contact A Significant Improvement for Surgical Oncology ...
by Devices and Pharma | May 7, 2024 | Alerts, Alerts-Pharma, Consumer Information, Consumer Safety, FDA Safety Communication, FDA_Counterfeit_Products, Industry News, MedWatch-System, Pharmaceuticals, Product Quality, Product Safety, Products_Drugs, Reg_Products, US-FDA
FDA Warns about Counterfeit Botox Products Incidents from use by licensed practitioners and unlicensed individuals Home About Consumer Medical Devices Pharma AI Regulatory Quality News Enforcement Alerts Innovation My Account Contact Real Botox Packaging Real Botox...
by Devices and Pharma | May 5, 2024 | Consumer Information, FDA Approvals, Industry News, New Drugs, New Pharma Products, Pharmaceuticals, Product-Innovation, Products_Drugs, US-FDA
FDA Approves First Drug to Treat WHIM Syndrome Approval of Xolremdi (mavorixafor) capsules a significant milestone Home About Consumer Medical Devices Pharma AI Regulatory Quality News Enforcement Alerts Innovation My Account Contact A Breakthrough for Rare...