BfArM RSS-Feed: Medical Devices
- 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
- DiGA
- DiGA
- BfArM Recommendations
- Exemption criteria and risk assessment summary within clinical investigations or performance evaluation studies
- Troubleshooting: View PDF documents with Firefox
BfArM RSS-Feed: Pharmacovigilance
- Basis for the ongoing monitoring and improvement of drug safety
- Boards and committees
- Expert Advisory Committee for Pharmacy-Only Issues
- Expert Advisory Committee for Prescription-Only Issues
- Routine sessions pursuant to Section 63 German Medicines Act (AMG)
- PSUR Repository
- Contact persons for Pharmacovigilance
- FAQ "Pharmacovigilance"
- Dear Doctor Letter (available in German only)
- Information for patients (available in German only)
FDA D.I.S.C.O
- FDA D.I.S.C.O. Burst Edition: FDA approval of Brukinsa (zanubrutinib) for adult patients with Waldenström’s macroglobulinemia
- FDA D.I.S.C.O. Burst Edition: FDA approval of Tibsovo (ivosidenib) for adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with an isocitrate dehydrogenase-1 mutation as detected by an FDA-approved test
- FDA D.I.S.C.O. Burst Edition: FDA approvals of Jemperli (dostarlimab-gxly) for patients with mismatch repair deficient recurrent or advanced solid tumors, and Opdivo (nivolumab) for the adjuvant treatment of patients with urothelial carcinoma
- FDA D.I.S.C.O. Burst Edition: FDA approval of Welireg (belzutifan) for adult patients with von Hippel-Lindau disease who require therapy for associated renal cell carcinoma, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors, not requiring immediate surgery
- FDA D.I.S.C.O. Burst Edition: FDA approval of Lenvima (lenvatinib) in combination with Keytruda (pembrolizumab) for first-line treatment of adult patients with advanced renal cell carcinoma
- FDA D.I.S.C.O. Burst Edition: FDA approval of Keytruda (pembrolizumab) for high-risk early-stage triple-negative breast cancer
- FDA D.I.S.C.O. Burst Edition: FDA approval of Keytruda (pembrolizumab) in combination with Lenvima (lenvatinib) for advanced endometrial carcinoma
MedWatch Safety Alerts RSS Feed
- Left Atrial Appendage Occlusion (LAAO) Devices Potentially Associated with Procedural Outcome Differences Between Women and Men – Letter to Health Care Providers
- Eli Lilly and Company Issues Voluntary Nationwide Recall of One Lot of GLUCAGON® Emergency Kit Due to Loss of Potency
- 2021 Medical Device Recalls
- Armstrong Medical Limited Recalls AMSORB PLUS PREFILLED G-CAN 1.0L Due to Reduced Gas Flow to Patients During Anesthesia
- Medtronic Recalls Pipeline Flex Embolization Devices for Risk of Delivery System Fractures During Placement, Retrieval, or Movement of Device