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US FDA Setting Up Shop in China

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2008-03-20 08:00:01 by Tim in Medgadget
...FDA staff From the FDA: This is an important step forward in the FDA's plans to hire and place FDA staff in China over the next 18 months. In addition, the FDA will be hiring a total of five local Chinese nationals to work with the new FDA staff at the U.S. Embassy in Beijing and the U.S. Consulates General in Shanghai and Guangzhou In an age...
 
Tags: fda, fda staff, china, food, safe food, drug administration, shop, regulatory, product quality
 
 
 
 
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CryoValve Approved by FDA

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2008-02-08 19:56:23 by Michael in Medgadget
...FDA has given approval to CryoValve SG pulmonary human heart valve, an allograft based on CryoLife 's SyneGraft technique that removes cells and cell fragments from cadaveric heart valves. The remaining matrix is thought to be less prone to attack by the immune system. Traditionally, when human tissue is recovered from a cadaver for future...
 
Tags: fda, allograft heart valves, heart valves, allograft, valved-conduit allograft, fda welcomes innovations, tissue, human tissue, cryolife press release
 
 
 
 
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FDA OK's Real-Time Test for Respiratory Viruses

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2008-01-18 20:40:43 by Michael in Medgadget
...FDA, and was CE Mark'ed by the European Union in the past. The company touts that it is "the first real-time molecular diagnostic test for respiratory viruses to receive FDA clearance ... also it is the first cleared real time molecular infectious disease test to detect as many as three organisms simultaneously Here's what the FDA says: These...
 
Tags: respiratory viruses, fda, viruses, test, real-time test, proflu test, proflu, fda clears, receive fda clearance
 
 
 
 
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FDA Approves ARTISS Slow-Setting Fibrin Sealant for Treatment of Burn Patients

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2008-03-25 08:00:01 by Michael in Medgadget
...FDA: Fibrin sealants are tissue adhesives that contain the proteins fibrinogen and thrombin, which are essential in the clotting of blood. Artiss (Fibrin Sealant, VH S/D 4) differs from other fibrin sealants in that it contains a lower concentration of thrombin. This lower concentration allows surgeons more time to position skin grafts over...
 
Tags: artiss, fibrin sealant, artiss fibrin sealant, patients, skin, position skin grafts, fda, fda approves, skin graft
 
 
 
 
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FDA Claims Faster Device Approvals

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2008-06-24 08:15:51 by Michael in Medgadget
...FDA's Office of Device Evaluation has released a report of its activities for fiscal years 2006 and 2007. Among other things, the FDA is claiming that its approval process has been expedited, allowing for faster answers to device approval applications Pharmalot reports: In a new report, the agency maintains it is now faster at approving...
 
Tags: fda, approval, approval process, fda office, office, device evaluation report, device evaluation, device approval applications, faster
 
 
 
 
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FDA OK's Voluven for Post-operative Blood Loss

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2008-01-02 19:49:21 by Michael in Medgadget
...FDA has approved a novel hydroxyethyl starch (HES) solution called Voluven, from Fresenius Kabi , a Bad Homburg, Germany company, for treatment of post-operative volume loss. This lower substituted hydroxyethyl starch volume expander was found in numerous studies to effectively treat hypovolemia with a minimum number of coagulation side...
 
Tags: blood, blood vessels, blood volume expanders, volume, massive blood loss, blood plasma, equivalent volume, blood volume, post-operative volume loss
 
 
 
 
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Medtronic's Endeavor Drug-Eluting Stent Approved by FDA

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2008-02-01 18:25:31 by Michael in Medgadget
...FDA approval of its Endeavor Zotarolimus-Eluting Coronary Stent System, the first drug eluting stent approved since 2004. The approval, following a number of controversies in the past years involving drug eluting stents, rests on the condition that Medtronic continues its post-market clinical monitoring program From the press release: The...
 
Tags: endeavor, stent, endeavor stent, taxus, taxus patients, endeavor patients, stent thrombosis, taxus stent, coronary stent system
 
 
 
 
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FDA Issues Guidance for Drug Eluting Stents

2008-03-26 17:57:04 by Michael in Medgadget
 
...FDA has issued guidance notes for the industry for the development, testing, clinical studies, and manufacture of the devices From the FDA: This draft guidance, announced in today's Federal Register discusses the development pathway for new drug-eluting stents and provides recommendations on information necessary for a complete marketing...
 
Tags: stents, guidance, fda, drug, stents- nonclinical, stents combine device, device, draft guidance, fda document
 
 
 
 
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Mercury Drama: FDA Settles Dental Filling Lawsuit

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2008-06-06 20:56:55 by jhbarad in Medgadget
...FDA settled a lawsuit yesterday and agreed to complete a regulatory review on the dangers of Mercury amalgam dental fillings. The FDA also updated some of the safety concerns on its website to say: Dental amalgams contain mercury, which may have neurotoxic effects on the nervous systems of developing children and fetuses. When amalgam...
 
Tags: mercury, release mercury vapor, mercury vapor, fda, fillings, fillings pose, release, final decision, short-term data exposure