BfArM RSS-Feed: Medical Devices
- Updated BfArM recommendation
- Medical Devices
- Market Access
- Recommends to stop using of dialysers
- Legislation
- Silicone gel breast implants from Poly Implant Prothèse Company - Information
- Termination and Abortion of investigations
- Subsequent Amendments
- FAQ on Medical Devices - Clinical Investigations
- Legal Framework
BfArM RSS-Feed: Pharmacovigilance
- Ifosfamide: review of encephalopathy risk
- Dear Doctor Letter (Rote-Hand-Brief) on metamizole: risk of drug-induced liver injury
- Dear Doctor Letter (Rote-Hand-Brief) on Esbriet®: important safety update and new recommendations to prevent Drug-Induced Liver Injury (DILI)
- Dear Doctor Letter (Rote-Hand-Brief) on systemic and inhaled fluoroquinolones: risk of heart valve regurgitation/incompetence
- Dear Doctor Letter (Rote-Hand-Brief) on Tecfidera® (dimethyl fumarate): updated recommendations in the light of cases of progressive multifocal leukoencephalopathy (PML) in the setting of mild lymphopenia
- Dear Doctor Letter (Rote-Hand-Brief) on Gilenya® (fingolimod): updated recommendations to minimise the risk of drug-induced liver injury (DILI)
- Information for marketing authorisation holders: current information on submission for step 2
- Hydroxychloroquine and Chloroquine: psychiatric disorders
- Dear Doctor Letter (Rote-Hand-Brief) on Gliolan® (5-aminolevulinic acid, 5-ALA): what to do in case of delayed surgery and information on fluorescence in non high-grade glioma
- Ranitidine: EMA reviews ranitidine-containing drugs based on detection of NDMA
What's New: Drugs RSS Feed
- Recently Issued Guidance Documents
- Drug Supply Chain Security Act pilot project program and enhanced drug distribution security - 12/08/2020 - 12/09/2020
- What's New Related to Drugs
- Guidance, Compliance, & Regulatory Information
- Environmental Impact Statement (EIS) for Certain Sunscreen Drug Products
- Patent Certifications and Suitability Petitions
FDA D.I.S.C.O
- FDA D.I.S.C.O. Burst Edition: FDA approvals of Jemperli (dostarlimab-gxly) for adults with mismatch repair deficient recurrent or advanced endometrial cancer and Zynlonta (loncastuximab tesirine-lpyl) for adults with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy
- FDA D.I.S.C.O. Burst Edition: FDA approvals of Erbitux (cetuximab) for K-Ras wild type, EGFR-expressing colorectal cancer or squamous cell carcinoma of the head and neck and Trodelvy (sacituzumab govitecan) for patients with unresectable locally advanced or metastatic triple negative breast cancer
- FDA D.I.S.C.O. Burst Edition: FDA approval of Sarclisa (isatuximab-irfc) in combination with carfilzomib and dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy
- FDA D.I.S.C.O. Burst Edition: FDA approval of ABECMA (idecabtagene vicleucel) the first FDA approved cell-based gene therapy for the treatment of adult patients with relapsed or refractory multiple myeloma
- FDA D.I.S.C.O. Burst Edition: FDA approval of Keytruda (pembrolizumab) for patients with metastatic or locally advanced esophageal or gastroesophageal carcinoma
- FDA D.I.S.C.O. Burst Edition: FDA approval of Fotivda (tivozanib) for adult patients with relapsed or refractory advanced renal cell carcinoma following two or more prior systemic therapies
- FDA D.I.S.C.O. Burst Edition: Yescarta (axicabtagene ciloleucel) for adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy
MedWatch Safety Alerts RSS Feed
- 2021 Medical Device Recalls
- Medtronic, Inc. Recalls Instructions for Use and Patient Manual for HeartWare HVAD System to Update Information about Carrying Case, Driveline Cover, and Controller Power-Up Issues
- Yamtun7 Issues Voluntary Nationwide Recall of Poseidon Platinum 3500 Due to the Presence of Undeclared Tadalafil and Sildenafil
- Novo Nordisk Issues Voluntary Nationwide Recall of Levemir®, Tresiba®, Fiasp®, Novolog® and Xultophy® Product Samples Due to Improper Storage Temperature Conditions
- Hospira Issues A Voluntary Nationwide Recall for One Lot of Sterile Water for Injection, USP, Due to the Potential Presence of Visible Particulate