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
- DiGA
- DiGA
- BfArM Recommendations
- Exemption criteria and risk assessment summary within clinical investigations or performance evaluation studies
What's New: Drugs RSS Feed
- CDERLearn Training and Education
- What's New Related to Drugs
- Drugs@FDA Data Files
- Public Webinar - Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments – Draft Guidance - 09/09/2022
- Endocrinologic and Metabolic Drugs Advisory Committee Roster
- GDUFA Paid Facilities List
FDA D.I.S.C.O
- FDA D.I.S.C.O. Burst Edition: FDA approval of Xalkori (crizotinib) for ALK-positive inflammatory myofibroblastic tumor
- FDA D.I.S.C.O. Burst Edition: FDA approval of Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for unresectable or metastatic solid tumors with BRAF V600E mutation
- FDA D.I.S.C.O. Burst Edition: FDA approval of Breyanzi (lisocabtagene maraleucel) for second-line treatment of large B-cell lymphoma
- FDA D.I.S.C.O. Burst Edition: FDA approvals of Opdivo in combination with chemotherapy and Opdivo in combination with Yervoy for first-line advanced or metastatic esophageal squamous cell carcinoma, and Kymriah (tisagenlecleucel) for relapsed or refractory follicular lymphoma
- FDA D.I.S.C.O. Burst Edition: FDA approval of Tibsovo (ivosidenib) in combination with azacitidine for newly diagnosed acute myeloid leukemia with a susceptible IDH1 mutation, as detected by an FDA-approved test in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy
- FDA D.I.S.C.O. Burst Edition: FDA approval of Vidaza (azacitidine) for pediatric patients with newly diagnosed juvenile myelomonocytic leukemia
- FDA D.I.S.C.O. Burst Edition: FDA approval of Enhertu (fam-trastuzumab deruxtecan-nxki) for adult patients with unresectable or metastatic HER2-positive breast cancer
MedWatch Safety Alerts RSS Feed
- 2022 Medical Device Recalls
- Haimen Shengbang Laboratory Equipment Co. Ltd. Recalls Viral Transport Media Containers That Are Not Authorized, Cleared, or Approved by the FDA
- VI-Jon, LLC Expands Voluntary Worldwide Recall of All Flavors and Lots within Expiry of Magnesium Citrate Saline Laxative Oral Solution Due to Microbial Contamination
- Plastikon Healthcare Expands Voluntary Nationwide Recall of Milk of Magnesia Oral Suspension and Magnesium Hydroxide /Aluminum Hydroxide /Simethicone Oral Suspension Due to Microbial Contamination
- Loud Muscle Science, LLC Issues Voluntary Recall of Launch Sequence Capsules Due to the Presence of Undeclared Tadalafil in United States and Canada