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(ANI) and its subcontractor Qorvis Communications to create a public awareness campaign to burnish the agency’s image. Read More FDA Highlights Severe Skin Reactions With RevlimidThe FDA is cautioning physicians that Celgene’s multiple myeloma treatment Revlimid might be associated with serious skin reactions from Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). Read More Drugmakers to Establish Generics Venture in JapanIsraeli drugmaker Teva Pharmaceutical Industries is joining with Japan’s Kowa to create a Japanese generics firm they hope will achieve sales of $1 billion in 2015. Read More Industry, GAO Disagree on Cost of Reimbursement Cuts for Imaging ServicesCuts in Medicare reimbursements for physician imaging services as a result of controversial provisions in the Deficit Reduction Act of 2005 were more than intended by Congress and have contributed to hard times for the imaging industry, according to industry groups. Read More Randomized, Controlled Trials Needed for Incontinence DevicesRandomized, controlled clinical trials are generally the least burdensome way to collect safety and effectiveness data for urinary incontinence devices, the FDA says in a draft guidance. Read More FDA Clears Interrad Catheter with Subcutaneous Securement SystemInterrad Medical has received 510(k) clearance for its SecureAcath PICC, a catheter with a subcutaneous securement system. Read More More Top StoriesSponsored by: az_adjs(99,'fda3b64690');TOP STORIES TOP DEVICE STORIESTOP DRUG STORIES RSS Industry, GAO Disagree on Cost of Reimbursement Cuts for Imaging ServicesCuts in Medicare reimbursements for physician imaging services as a result of controversial provisions in the Deficit Reduction Act of 2005 were more than intended by Congress and have contributed to hard times for the imaging industry, according to industry groups. Read More Randomized, Controlled Trials Needed for Incontinence DevicesRandomized, controlled clinical trials are generally the least burdensome way to collect safety and effectiveness data for urinary incontinence devices, the FDA says in a draft guidance. Read More FDA Clears Interrad Catheter with Subcutaneous Securement SystemInterrad Medical has received 510(k) clearance for its SecureAcath PICC, a catheter with a subcutaneous securement system. Read More FDA Updates Two 510(k) Marketing GuidancesMakers of ultrasound equipment and intravascular (IV) administration sets and accessories have updated guidance to direct them through the FDA’s marketing process. Read More CMS Solicits Nominees for DMEPOS Advisory PanelThe Centers for Medicare & Medicaid Services (CMS) is soliciting nominations for candidates to serve on its program advisory and oversight committee that advises on issues dealing with the competitive bidding program for durable medical equipment, prosthetics, orthotics and supplies (DMEPOS). Read More FDA Cites Device Trial Investigator for Not Reporting UADEsThe chief of vascular surgery at a university medical center enrolled ineligible subjects in a device clinical trial and did not report unanticipated adverse device effects (UADEs) as required, according to an FDA warning letter. Read More More Top Device StoriesTOP STORIES TOP DEVICE STORIES TOP DRUG STORIESRSS FDA Highlights Severe Skin Reactions With RevlimidThe FDA is cautioning physicians that Celgene’s multiple myeloma treatment Revlimid might be associated with serious skin reactions from Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). Read More Drugmakers to Establish Generics Venture in JapanIsraeli drugmaker Teva Pharmaceutical Industries is joining with Japan’s Kowa to create a Japanese generics firm they hope will achieve sales of $1 billion in 2015. Read More EMEA Seeks Solutions to Radioisotope ShortagesThe European Medicines Agency (EMEA) is encouraging sponsors to implement alternative manufacturing processes for technetium-99 generators to alleviate a supply crunch prompted by the temporary shutdown of a nuclear reactor in Petten, Netherlands. Read More Allegations of False Study Results May Get Investigators DisqualifiedTwo physicians who oversaw unrelated drug trials have been notified that they may be disqualified as clinical investigators due to accusations that they submitted false information to study sponsors. Read More Expert: Leave FDA Free to Create Biogenerics Approval PathAs Congress drafts legislation to create a pathway for biogeneric approval, lawmakers should limit mandates that could hinder the FDA’s ability to make decisions about clinical trials and bioequivalence testing, Gregory Conko, a senior fellow at the Competitive Enterprise Institute, said at the Generic Pharmaceutical Association’s Annual Policy Conference. Read More More Top Drug StoriesFEATURED PRODUCTS Third Annual FDA Inspections SummitPrice: $1,997 Hear top FDA officials and industry leaders provide insight on what to expect in 2009 and how to better manage your inspections and compliance strategies. You'll participate in intensive workshops, listen to keynote presentations by officials and experts and choose among three specialized tracks (drugs/biologics, devices and clinical trials) focusing on the latest inspections strategies.View Product Featured Product Sponsored by: az_adjs(100,'fda8e231b1'); Clinical Trials Indemnification Clauses: Pitfalls and Problems to AvoidPrice: $277 Clinical Trials Indemnification Clauses: Pitfalls and Problems to Avoid is the management report that examines the most problematic areas in negotiating indemnification clauses. This report highlights the key topics you need to address and provides insight into the types of agreements that are generally accepted standards in the industry.View Product Featured Product Sponsored by: az_adjs(101,'fda178c9ef'); az_adjs(98,'fda7056d45'); HomeFDAnews StoreDatabasesAbout UsContact UsSite MapPrivacy Policy 300 N. 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Twice-monthly | newsletter | devoted | to | helping | clinical | research | sites | improve | operations. |
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Clinical Trials Advisor 2008 October
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