http://www.schwoebel.net/wp002 Regulatory Affairs Updates and Bulletins by Joe Schwoebel Thu, 11 Dec 2008 05:00:00 +0000 http://backend.userland.com/rss092 en The E-LUMINEXX Vascular Stent is a thin, flexible metal mesh tube that can be implanted in the large arteries that supply blood to the pelvis and legs (iliac arteries). http://www.schwoebel.net/wp002/2008/12/10/consumer-information-on-e-luminexx-vascular-stent-p080007/ Reason for Recall: Some packages were mislabeled. The syringes labeled for use with U-40 unit insulin were mixed with syringes labeled for use with U-100 insulin. http://www.schwoebel.net/wp002/2008/11/05/class-i-medical-device-recall-tyco-healthcare-group-lp-covidien-relion-insulin-syringes-1cc-31-gauge/ Reason for Recall: This device was not approved by FDA, lacked safety and effectiveness data, and was not manufactured under current good manufacturing practices. http://www.schwoebel.net/wp002/2008/10/02/class-i-medical-device-recall-nebion-llc-hlx-8-magnetic-resonance-device/ The SPOT-Light ® HER2 CISH ™ kit is a laboratory test that uses DNA probes to measure the number of copies of Her-2 gene on chromosome 17 in breast cancer cells by a chromogenic method. http://www.schwoebel.net/wp002/2008/07/31/consumer-information-on-invitrogen-spot-light%c2%ae-her2-cish%e2%84%a2-kit-p050040/ Reason for Recall: Use of the Valleylab Force FX-C or Valleylab SSE2L with the CentriMag Blood Pumping System may result in stoppage of the pump and may cause serious injury or death. http://www.schwoebel.net/wp002/2008/07/31/class-i-medical-device-recall-levitronix-centrimag-extracorporeal-blood-pumping-system-centrimag-primary-console-with-v200-application-software-on-board/ Evolence® Collagen Filler is a sterile, injectable, biodegradable, yellowish, opaque gel that is injected into the inner layers of facial skin (mid to deep dermis) in order to correct moderate to deep facial wrinkles and folds such as those around the... http://www.schwoebel.net/wp002/2008/07/24/consumer-information-on-evolence%c2%ae-collagen-filler-p070013/ Main Category: Pain / Anesthetics Also Included In: Clinical Trials / Drug Trials ; Pharma Industry / Biotech Industry Article Date: 12 Jul 2008 - 0:00 PDT NeurogesX, Inc. http://www.schwoebel.net/wp002/2008/07/13/neurogesx-initiates-dosing-in-phase-1-clinical-trial-for-ngx-1998-capsaicin-liquid-formulation/ The Medtronic ® Attain StarFix™ Model 4195 Lead is a surgically implanted insulated wire that is designed to be used as a part of a biventricular pacemaker system. The 4195 lead is designed to be implanted in a branch of the coronary vein that goes over.. http://www.schwoebel.net/wp002/2008/07/10/consumer-information-on-medtronic%c2%ae-attain-starfix%e2%84%a2-model-4195-lead-p060039/ The XIENCE V Stent is a metal scaffold with the drug everolimus contained in a thin coating. The XIENCE V Stent is mounted on a folded balloon attached to a catheter delivery system, for placement into the coronary artery (blood vessel supplying blood... http://www.schwoebel.net/wp002/2008/07/02/consumer-information-on-xience%e2%84%a2-v-everolimus-eluting-coronary-stent-on-the-over-the-wire-otw-or-rapid-exchange-rx-stent-delivery-systems-p070015/ The Zenith® TX2 ® Thoracic TAA Endovascular Graft with the H&LB One-Shot™ Introduction System is used to repair aneurysms of the aorta in the chest. An aneurysm is a diseased, weakened and bulging section of an artery wall. http://www.schwoebel.net/wp002/2008/07/02/consumer-information-on-zenith%c2%ae-tx2%c2%ae-thoracic-taa-endovascular-graft-with-the-hlb-one-shot%e2%84%a2-introduction-system-p070016/ GlaxoSmithKline Plc does not expect to win U.S. approval for its key cervical cancer vaccine Cervarix until late 2009, marking a further delay for the product. http://www.schwoebel.net/wp002/2008/06/30/glaxos-cervarix-vaccine-faces-further-delay/ Oncolytics Biotech Inc. announced today that following U.S. Food and Drug Administration review, the Company is initiating a U.S. Phase 2 clinical trial using intravenous administration of REOLYSIN in ... http://www.schwoebel.net/wp002/2008/06/22/r-e-p-e-a-t-oncolytics-biotech-inc-announces-us-phase-2/ US FDA seeks India post for food, drug checksReuters India, India - 29 minutes agoBy Lisa Richwine and Susan Heavey WASHINGTON (Reuters) - The US Food and Drug Administration hopes to establish operations in India by year's end to better ... http://in.reuters.com/article/businessNews/idINIndia-34166620080621 Warning issued about stop-smoking drugGlobe and Mail, Canada - 5 hours agoThe US Food and Drug Administration made a similar announcement in February.And last month, US officials banned pilots and air-traffic controllers from ... http://www.theglobeandmail.com/servlet/story/LAC.20080621.DRUG21/TPStory/National Commentary: Toward a Fuller Understanding of Business Risks in ChinaUS-China Today, CA - 13 hours agoWithin the last few weeks, US Food and Drug Administration (FDA) investigators have stated that the contamination appears to be an intentional criminal act ...New Foreign Drug Trial Rule Coming Law.com (subscription)all 2 news articles http://www.schwoebel.net/wp002/2008/06/20/commentary-toward-a-fuller-understanding-of-business-risks-in-china-us-china-today/