BfArM RSS-Feed: Medical Devices
- Critical vulnerabilities in the real-time operating systems of various venders
- Field Corrective Actions
- 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
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
- FAQ "Pharmacovigilance"
- Dear Doctor Letter (available in German only)
- Information for patients (available in German only)
- List of Pharmaceutical Substances and Preparations
What's New: Drugs RSS Feed
- CDERLearn Training and Education
- Orange Book Preface
- What's New Related to Drugs
- Ongoing | Cancer Accelerated Approvals
- Fat Burners Zone Issues Voluntary Nationwide Recall of Zero Xtreme Due to Presence of Undeclared Sibutramine
- Acella Pharmaceuticals, LLC Issues Voluntary Nationwide Recall of Certain Lots of NP Thyroid® (Thyroid Tablets, USP) Due to Super Potency
FDA D.I.S.C.O
- FDA D.I.S.C.O. Burst Edition: FDA approval of Orencia (abatacept) for prophylaxis of acute graft versus host disease
- FDA D.I.S.C.O. Burst Edition: FDA approvals of Rituxan (rituximab) plus chemotherapy for pediatric cancer indications, and Keytruda (pembrolizumab) for adjuvant treatment of Stage IIB or IIC melanoma
- FDA D.I.S.C.O. Burst Edition: FDA approvals of Cytalux (pafolacianine) for identifying malignant ovarian cancer lesions and Darzalex Faspro (daratumumab + hyaluronidase-fihj), Kyprolis (carfilzomib) and dexamethasone for multiple myeloma
- FDA D.I.S.C.O. Burst Edition: FDA approval of Fyarro (sirolimus protein-bound particles for injectable suspension (albumin-bound)) for locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor
- FDA D.I.S.C.O. Burst Edition: FDA approval of Keytruda (pembrolizumab) for the adjuvant treatment of patients with renal cell carcinoma at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions
- FDA D.I.S.C.O. Burst Edition: FDA approval of Scemblix (asciminib) for patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase, previously treated with tyrosine kinase inhibitors, and for adult patients in chronic phase with the T315I mutation
- FDA D.I.S.C.O. Burst Edition: FDA approval of Tecentriq (atezolizumab) for adjuvant treatment following resection and platinum-based chemotherapy in patients with stage II to IIIA non-small cell lung cancer
MedWatch Safety Alerts RSS Feed
- Getinge USA Sales, LLC Recalls the Vaporizer Sevoflurane Maquet Filling for Flow Family Anesthesia Systems Due to a Risk of Harmful Chemical Exposure
- 2022 Medical Device Recalls
- Sodium Citrate Blood Specimen Collection Tube Conservation Strategies – Letter to Health Care and Laboratory Personnel
- Mylan Pharmaceuticals Inc., a Viatris Company, Conducting Voluntary Recall of One Batch of Semglee® (insulin glargine injection), 100 units/mL (U-100), 3 mL Prefilled Pens, Due to the Potential for a Missing Label in the Batch
- UPDATE: Blood Specimen Collection Tube Conservation Strategies - Letter to Health Care and Laboratory Personnel