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Title: Biotechnology and Pharmaceuticals/Pharmaceuticals/News and Media - Clinical Trials Advisor Twice-monthly newsletter devoted to helping clinical research sites improve operations.
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Multiple Investigations of FDA PR Contract Under Way

Three separate investigations have been launched into the FDA’s awarding of a sole source contract, which may have skirted government contracting rules, to Alaska Newspapers Inc. (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 Revlimid

The 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 Japan

Israeli 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 Services

Cuts 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 Devices

Randomized, 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the least burdensome way to collect safety and effectiveness data for urinary incontinence devices, the FDA says in a draft guidance.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 System

Interrad Medical has received 510(k) clearance for its SecureAcath PICC, a catheter with a subcutaneous securement system. Read More 

More Top Stories

Sponsored by: az_adjs(99,'fda3b64690');TOP STORIES TOP DEVICE STORIESTOP DRUG STORIES RSS 

Industry, GAO Disagree on Cost of Reimbursement Cuts for Imaging Services

Cuts 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 Devices

Randomized, 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 System

Interrad 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 Guidances

Makers 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 Panel

The 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 UADEs

The 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 

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TOP STORIES TOP DEVICE STORIES TOP DRUG STORIESRSS 

FDA Highlights Severe Skin Reactions With Revlimid

The 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 Japan

Israeli 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 Shortages

The 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 Disqualified

Two 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 Path

As 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 

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http://www.fdanews.com/

Clinical Trials Advisor 2008 October

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