BfArM RSS-Feed: Medical Devices
- 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
- Silicone gel breast implants from Poly Implant Prothèse Company - Information
What's New: Drugs RSS Feed
- VistaPharm LLC Issues Voluntary Nationwide Recall of Sucralfate Oral Suspension, 1g/10mL Due to Microbial Contamination Identified as Bacillus Cereus
- Increasing the Efficiency of Biosimilar Development Programs--Reevaluating the Need for Comparative Clinical Efficacy Studies - 09/12/2023
- FDA Roundup: September 22, 2023
- Compounding: Inspections, Recalls, and other Actions
- User Fee Lists
- What's New Related to Drugs
FDA D.I.S.C.O
- FDA D.I.S.C.O. Burst Edition: FDA approval of Lynparza (olaparib), with abiraterone and prednisone, for BRCA-mutated metastatic castration-resistant prostate cancer
- FDA D.I.S.C.O. Burst Edition: FDA approval of Epkinly (epcoritamab-bysp) for relapsed or refractory diffuse large B-cell lymphoma and high-grade B-cell lymphoma
- FDA D.I.S.C.O. Burst Edition: FDA approval of Polivy (polatuzumab vedotin-piiq) for previously untreated diffuse large B-cell lymphoma, not otherwise specified, and high-grade B-cell lymphoma
- FDA D.I.S.C.O. Burst Edition: FDA approval of Omisirge (omidubicel-onlv) to reduce time to neutrophil recovery and infection in patients with hematologic malignancies
- FDA D.I.S.C.O. Burst Edition: FDA approval of Padcev (enfortumab vedotin-ejfv) with Keytruda (pembrolizumab) for locally advanced or metastatic urothelial carcinoma
- FDA D.I.S.C.O. Burst Edition: FDA approval of Zynyz (retifanlimab-dlwr) for metastatic or recurrent locally advanced Merkel cell carcinoma
- FDA D.I.S.C.O. Burst Edition: FDA approval of Tafinlar (dabrafenib) with Mekinist (trametinib) for pediatric patients with low-grade glioma with a BRAF V600E mutation
MedWatch Safety Alerts RSS Feed
- Hamilton Medical Inc. Recalls HAMILTON-C1, C2, C3, T1 Ventilators for Software Issues that May Cause Ventilators to Stop Without Notice
- VistaPharm LLC Issues Voluntary Nationwide Recall of Sucralfate Oral Suspension, 1g/10mL Due to Microbial Contamination Identified as Bacillus Cereus
- Universal Meditech Inc. Expands Nationwide Recall to All Products Manufactured between March 2021 and November 2022
- Medline Industries Recalls Hudson RCI Addipak Unit Dose Vial, 0.9% Full Normal Saline Solution Due to Being Non-Sterile
- 2023 Medical Device Recalls