Fda sir-sphere
WebDec 7, 2024 · The Design History File (DHF) is a collection of documents that outlines the design history of a medical device. A DHF is one of the first documents that a regulatory body such as the FDA inspects for accrediting purposes. The primary function of the DHF is to provide documented evidence that the device’s design phase is following the ... Web1 The FDA provides PMA guidance on the clinical data accepted to support medical device applications and submissions.2 TheraSphere requires a Radioactive Material License …
Fda sir-sphere
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WebU.S. Food and Drug Administration (FDA) on March 21, 2024. Sirtex Medical’s PMA for the Sir-Sphere® Y-90 resin microspheres was approved by the FDA March 5, 2002. 2. … WebNov 11, 2015 · Drug: Tas-102 Device: SIR-Sphere: Phase 1: Detailed Description: Randomized studies have demonstrated that Tas-102 has single agent activity against chemotherapy refractory colorectal cancer. A recent pre-clinical study has shown that Tas-102 may have activity as a radiation sensitizer in bladder cancer cell lines. Benefit of …
WebApr 26, 2024 · FDA Places Clinical Hold on Phase 1 Trial of XMT-2056 in HER2-expressing Solid Tumors. March 13th 2024. AB011 Plus CAPOX Demonstrates Preliminary Safety, Efficacy in Advanced Gastric/GEJ Cancer. WebMar 18, 2024 · FDA approval has been granted to the TheraSphere Y-90 Glass Microspheres for the treatment of unresectable hepatocellular carcinoma (HCC), …
WebMar 22, 2024 · The DOORwaY90 study has the potential to expand the FDA-approved indication for use of SIR-Spheres in the United States, which would mark an incredible … Webradioactive drug producer (30.34), or equivalent Agreement State requirements, or – Preparedby an ANP, or an AU who meets 35.290 or § § 35.390 with generator elution …
WebThe FDA Acronyms and Abbreviations database provides a quick reference to acronyms and abbreviations related to Food and Drug Administration (FDA) activities. The emphasis is on scientific,...
WebU.S. Food & Drug Administration 10903 New Hampshire Avenue Doc ID# 04017.04.18 Silver Spring, MD 20993 www.fda.gov Sirtex Medical US Holdings, Inc. October 23, … ga eagles vs az alkmaar hthWebSIR-Sphere: Study Arm (s) Active Comparator: sorafenib group Patients will receive continuous oral treatment with 800 mg of sorafenib daily (Nexavar, Bayer HealthCare Pharmaceuticals-Onyx Pharmaceuticals). Treatment interruptions and dose reductions (to 400 mg once daily) will be permitted for drug-related adverse effects. audi a6 assistenzpaket plusWebSIR sphere radioactive source -Yttrium is a beta emitter -The dose travels an average of 2.5 mm in tissue -Yttrium has a half-life of 64 hours -94% of the dose is delivered to the tumor in just over 11 days The use of SIR sphere technology is reffered to as SIRT (Selective internal radiation therapy) - also called radioembolization audi a6 assistenzpaket tourWebOct 23, 2015 · SIR-Spheres Y-90 resin microspheres are administered through a small catheter and inserted into the femoral artery. SIR-Spheres Y-90 resin microspheres are an FDA approved medical device intended for the treatment of colorectal cancer that has spread to the liver and cannot be surgically removed. audi a6 assistenzpaket tour inhaltWebThe FDA-approved product labeling for SIR-Sphere’s states that resectability may be evaluated via imaging with a triple phase contrast angio-portal CT scan or magnetic resonance imaging (MRI). The FDA-approved labeling for SIR-Sphere states that the following tests are recommended before treatment: ga eagles vs jong az alkmaar forebetWebK120615-081 2 Rev. 1 (03/2024) 1 2 DEVICE DESCRIPTION . The TheraSphere Yttrium-90 (Y-90) Glass Microsphere System consists of: • a sterile, single use, dose vial of TheraSphere,Y-90 Glass Microspheres,available in 3 GBq – 20 GBq audi a6 avant assistenzsystemeWebJul 8, 2013 · This phase I trial aims to establish, first, the tolerability of the combination of liver radioembolization with SirSpheres® and sorafenib in uveal melanoma patients with … ga eagles vs az alkmaar livescore