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FDA to hold workshop on accessible standardized medical device labeling (April 29-30)

Reed Smith LLP
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USA
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January 11 2013

On April 29 and 30, 2013, the Food and Drug Administration (FDA) is hosting a public workshop on "Accessible Standardized Medical Device Labeling." The

GAO flags concerns about implantable medical device information security

Reed Smith LLP
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USA
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October 16 2012

A recent GAO report warns of information security risks such as unauthorized changes of device settings resulting from a lack of appropriate access controls -- associated with the growing use of wireless technology in certain active implantable medical devices (e.g., implantable cardioverter defibrillators and insulin pumps

OIG examines dietary supplement claims, registration with FDA

Reed Smith LLP
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USA
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October 16 2012

The OIG has released two reports focusing on dietary supplements, one examining labeling claims and the other reviewing the FDA’s ability to identify and contact manufacturers in a public health emergency

OIG calls on CMS to implement safeguards for the Medicare prostheticsorthotics benefit

Reed Smith LLP
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USA
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October 15 2012

The OIG has issued a report, “CMS Has Not Promulgated Regulations To Establish Payment Requirements for Prosthetics and Custom-Fabricated Orthotics,” that calls on CMS to implement long-delayed statutory requirements and to better enforce regulatory standards for supplier documentation

House, Senate approve FDA User FeeDrug Safety Bills

Reed Smith LLP
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USA
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May 31 2012

On May 30, 2012, the House of Representatives voted 387-5 to approve H.R. 5651, the Food and Drug Administration Reform Act

FDA reports on post-approval drug safety monitoring

Reed Smith LLP
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USA
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May 11 2012

According to an April 24, 2012 Center for Drug Evaluation and Research (CDER) report, a strengthened and modernized post-market drug safety program has resulted in a substantial improvement in FDA’s oversight of drugs once they reach the American public

FDA issues final rule on sterility testing of biological products

Reed Smith LLP
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USA
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May 11 2012

On May 3, 2012 the FDA issued its final rule on sterility testing, amending the requirements for most licensed biological products effective June 4, 2012

Overview and analysis of the proposed federal sunshine

Reed Smith LLP
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USA
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January 30 2012

On December 19, 2011, the Centers for Medicare & Medicaid Services published a proposed rule related to section 6002 of the Affordable Care Act, commonly referred to as the “Physician Payment Sunshine Act”

FDA guidance on product name placement in advertising and promotional labeling

Reed Smith LLP
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USA
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January 25 2012

The FDA released a guidance document entitled ‘‘Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling’’ on January 25, 2012

OIG examines how Part D limits drugs to medically-accepted indications

Reed Smith LLP
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USA
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November 29 2011

According to a recent OIG report, “Ensuring That Medicare Part D Reimbursement Is Limited to Drugs Provided for Medically Accepted Indications,” Medicare Prescription Drug Plan sponsors do not have access to information necessary to ensure that Medicare Part D reimbursement is limited to drugs provided for medically-accepted indications (e.g., uses approved by Food and Drug Administration and supported by one or more of three specified compendia