New Human Medicines: RSS Feed from EMA
MedWatch Safety Alert RSS Feed
- Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Cefazolin for Injection Due to Product Mispackaging
- Angiographic Catheter Recall: Cook Removes Beacon Tip Angiographic Catheters due to Tip Separation
- mRNA COVID-19 Vaccines: FDA Safety Communication - FDA Approves Required Updated Warning in Labeling Regarding Myocarditis and Pericarditis Following Vaccination
- Early Alert: Esophageal pH Monitoring Capsule Issue from Medtronic
- Flexible Tracheostomy Tube Recall: Medtronic Removes Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula Due to Risk for Disconnection of the Flange from the Device Cannula
- Import Alerts for Certain Olympus Medical Devices Manufactured in Japan - Letter to Health Care Providers
- Medical Procedure Kits Correction: Medline Industries, LP Issues Correction for Medline Procedure Kits Containing Medtronic Aortic Root Cannula due to Potential Excess Material in Male Luers
- Transderm Scōp (Scopolamine Transdermal System): Drug Safety Communication - FDA Adds Warning About Serious Risk of Heat-Related Complications with Antinausea Patch
- Anesthesia Delivery Systems Recall: GE HealthCare Issues Correction for Certain Carestations due to Risk of Ineffective Ventilation When Used in Volume Control Ventilation (VCV) Mode
- Resuscitation System Recall: ZOLL Circulation, Inc. Recalls AutoPulse NXT Resuscitation System Due to a Failure Code That May Stop Compressions or Deliver Inadequate CPR
FDA Stay Informed on New Drugs
- Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Cefazolin for Injection Due to Product Mispackaging
- User Fee Lists
- OMUFA Performance Reports
- Recently Issued Guidance Documents
- Generic Drugs Forum (GDF) 2025 - 04/09/2025
- CDER Small Business and Industry Assistance (SBIA) Learn
- OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2025 User Fees and Registration - 05/20/2025
- Generic Drug Facilities, Sites and Organization Lists
- Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases – Questions and Answers
- For Healthcare Professionals | FDA’s Examples of Drugs that Interact with CYP Enzymes and Transporter Systems