RSS Feed from EMA on New Human Medicines
- Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 16-18 June 2026
- EMA Management Board: highlights of June 2026 meeting
- Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 June 2026
- EMA’s 2025 annual report shows strong approval numbers for human and veterinary medicines
- EMA, AMA and African regulatory authorities join forces on Ebola outbreak response
MedWatch Safety Alert RSS Feed
- Heart Pump Controller Correction: Abiomed Updates Use Instructions for Automated Impella Controllers
- Infant Resuscitation System Correction: GE HealthCare Issues Correction for Giraffe and Panda Infant Resuscitation Systems and Warmers with a M1091607-R Blender
- Early Alert: Catheter Introducer Issue from Abiomed and Oscor
- Catheter Recall Expansion: Medline Industries Removes Reprocessed Electrophysiology and Ultrasound Catheters
- UPDATE: Hintermann Series H3 Total Ankle Replacement Has a Higher-Than-Expected Risk of Device Failure: FDA Safety Communication
- Disruptions in Availability of Breast Biopsy Needles - Letter to Health Care Providers
- Early Alert: Convenience Kit Issue from Windstone Medical Packaging, Inc.
- Anesthesia Machine Correction: Draeger, Inc. Issues Correction for Atlan A350 and A350XL Anesthesia Workstations
- Convenience Kit Correction: Medline Issues Correction for Kits Containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP
- Beekeeper’s Naturals Issues Voluntary Nationwide Recall of Beekeeper’s Naturals Saline Nasal Spray Sold Through Amazon Due to Microbial Contamination
FDA Stay Informed on New Drugs
- IND Application Reporting: IND Safety Reports
- BsUFA IV: Fiscal Years 2028-2032
- Registered Outsourcing Facilities
- Recently Issued Guidance Documents
- Guidance Recap Podcast | Digital Health Technologies for Remote Data Acquisition in Clinical Investigations
- CDER Small Business and Industry Assistance (SBIA) Learn
- CDER Small Business & Industry Assistance (SBIA)
- Office of New Drugs Standard Safety Tables and Figures for New Drug and Biologic Applications - 06/23/2026
- Guidance Snapshot Pilot
- Over-The-Counter Monograph Drug User Fee Program (OMUFA)
