RSS Feed from EMA on New Human Medicines
- Human medicines European public assessment report (EPAR): Jelrix, autologous cartilage-derived articular chondrocytes, in-vitro expanded, Status: Application withdrawn
- Human medicines European public assessment report (EPAR): Imdylltra, tarlatamab, Status: Opinion
- Human medicines European public assessment report (EPAR): Adstiladrin, nadofaragene firadenovec, Status: Opinion
- Human medicines European public assessment report (EPAR): Zepzelca, lurbinectedin, Status: Opinion
- Human medicines European public assessment report (EPAR): Bopediat, furosemide, Status: Opinion
- Human medicines European public assessment report (EPAR): Joenja, leniolisib, Status: Opinion
- Human medicines European public assessment report (EPAR): Blarcamesine Anavex, blarcamesine, Status: Application withdrawn
- Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 14-16 April 2026
- EMA recommends authorisation of first veterinary vaccine using RNA technology
- Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 April 2026
- EMA consults on virtual control groups to help reduce animal use in medicines development
- EMA business hours over Easter holiday period
MedWatch Safety Alert RSS Feed
- Early Alert: Convenience Kit Issue from American Contract Systems
- Early Alert: Convenience Kit Issue from Medical Action Industries
- Ventilator Tubing Correction: Percussionaire Corporation Updates Use Instructions for Phasitron In-Line Valve
- Ventilator Correction: Philips Issues Correction for Trilogy Evo Platform Ventilators
- Reconstruction Prosthesis Correction: Stryker Updates Use Instructions for Patient-Fitted TMJ Implants
- Dialysis Catheter Recall: Merit Medical Removes 16F Dual-Valved Splittable Sheath Introducer
- Anesthesia Workstation Correction: Draeger Issues Correction for Atlan A350 and A350 XL
- Early Alert: Convenience Kit Issue from AVID Medical
- Early Alert: Sizing Catheter Issue from Cook Medical
- Ventilator Correction: Baxter Updates Use Instructions for Volara Single-Patient Use Circuits
FDA Stay Informed on New Drugs
- GDUFA IV: Fiscal Years 2028 – 2032
- Study Data Technical Conformance Guide - Technical Specifications Document
- FDA-TRACK: Prescription Drug User Fee Act Meeting Goals Summary
- FDA-TRACK: Prescription Drug User Fee Act Procedural Goals Summary
- FDA-TRACK: Prescription Drug User Fee Act Review Goals Summary
- Generic Drug User Fee Amendments
- Generic Drugs Program Monthly and Quarterly Activities Report
- Generic Drug Facilities, Sites and Organization Lists
- Establishing Impurity Specifications for Antibiotics
- MD Pharmaceutical Supply, LLC - 637815 - 04/13/2026