BfArM RSS-Feed: Medical Devices
- Notification of interruptions or discontinuations of the supply of a medical device
- DiGA and DiPA
- Critical vulnerabilities in the real-time operating systems of various venders
- Updated BfArM recommendation
- Damage of hip stem prostheses (neck area) caused by high-frequency cauterizing instruments (e. g. cautery knife)
- MIR-Changelog
- MIR changelog
- BfArM Recommendations
- Exemption criteria and risk assessment summary within clinical investigations or performance evaluation studies
- Troubleshooting: View PDF documents with Firefox
What's New: Drugs RSS Feed
- October 10, 2024: Meeting of the Cardiovascular and Renal Drugs Advisory Committee - 10/10/2024
- User Fee Lists
- Counterfeit Medicine
- Generic Drug Facilities, Sites and Organization Lists
- Internet Pharmacy Warning Letters
- Transderm Scōp (Scopolamine Transdermal System): Drug Safety Communication - FDA Adds Warning About Serious Risk of Heat-Related Complications with Antinausea Patch
FDA D.I.S.C.O
- FDA D.I.S.C.O. Burst Edition: FDA approval of Ryoncil (remestemcel-L-rknd) for steroid-refractory acute graft versus host disease in pediatric patients
- FDA D.I.S.C.O. Burst Edition: FDA approval of Bizengri (zenocutuzumab-zbco) for Treatment of adults with advanced unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy
- FDA D.I.S.C.O. Burst Edition: FDA approval of Tecelra (afamitresgene autoleucel) for unresectable or metastatic synovial sarcoma
- FDA D.I.S.C.O. Burst Edition: FDA approval of Keytruda (pembrolizumab) for unresectable advanced or metastatic malignant pleural mesothelioma
- FDA D.I.S.C.O. Burst Edition: FDA approvals of Augtyro (repotrectinib) for NTRK gene fusion-positive solid tumors and Krazati (adagrasib) for KRAS G12C-mutated colorectal cancer
- FDA D.I.S.C.O. Burst Edition: FDA approval of Retevmo (selpercatinib) for advanced or metastatic RET fusion-positive thyroid cancer
- FDA D.I.S.C.O. Burst Edition: FDA approval of Ojemda (tovorafenib) for relapsed or refractory pediatric low-grade glioma harboring a BRAF fusion or rearrangement, or BRAF V600 mutation
MedWatch Safety Alerts RSS Feed
- Transderm Scōp (Scopolamine Transdermal System): Drug Safety Communication - FDA Adds Warning About Serious Risk of Heat-Related Complications with Antinausea Patch
- Intra-Operative Positioning System Guidewire Recall: Centerline Biomedical Removes Certain IOPS Guidewires due to Delamination
- Blood Products Administration Set Recall: Fresenius Kabi Removes Large Volume Pump Blood Products Administration Sets due to Incorrect Assembly
- Convenience Kit Recall: Medline Industries, LP, Removes Medline Neonatal and Pediatric Kits containing Smiths Medical ORAL/NASAL Endotracheal Tubes Due to Smaller Than Expected Tube Diameter That May Cause Underventilation
- Aspiration Catheter Recall: Q’Apel Medical, Inc. Removes Hippo 072 Aspiration System and Cheetah Delivery Tool After FDA Warning Letter About Internal Processes and Distal Tip Characteristics