The 2012 JOBS Act: Fundamentally Changing the Way Companies Raise Capital
October 18, 2012
Recent changes in securities laws affect venture capital firms, angel investment groups, start up and early stage technology companies and emerging growth companies...
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Sixth Circuit Overturns $82.6 Million FCA Decision Against Fresenius
October 18, 2012
On Friday, October 5, 2012, the Sixth Circuit Court of Appeals overturned an $82.6 million judgment against Fresenius Medical Care Holdings ("Fresenius") in a...
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Annual Appellate Review - Cases that Matter to Business
October 18, 2012
Experienced members of Fulbright's Appellate Practice Group provided an overview of key decisions that will influence how your business operates and...
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FDA Considers Accelerated Approval Process for Certain Drugs
October 17, 2012
The U.S. Food and Drug Administration ("FDA") is considering plans to bring speedier U.S. approval to drugs deemed to offer greater societal benefits than risks...
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The OFCCP's New Compliance Developments
October 16, 2012
Under the Obama Administration, the Office of Federal Contract Compliance Programs (OFCCP) has had a record number of compliance audits and is demanding -- and...
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OIG Report Offers Corporate Integrity Agreement Best Practices
October 16, 2012
The U.S. Department of Health and Human Services Office of Inspector General ("OIG") held a roundtable discussion on August 7, 2012 in which OIG sought feedback...
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Study Finds CMS Penalty Did Not Change Hospital-Acquired Infection Rates
October 15, 2012
A 2008 policy from the Centers for Medicare & Medicaid Services ("CMS") that prohibits payments to hospitals for certain preventable hospital-acquired...
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Department of Health Launches a Consultation into its Proposals for Regulations on Commissioning in the NHS
October 12, 2012
As a result of the legislative changes implemented by the Health and Social Care Act 2012 (the "Act"), the Independent Regulator of National Health Service (&quo...
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GAO Report Evaluates 2010 Ambulance Costs, Reimbursement
October 11, 2012
On October 1, 2012, the Government Accountability Office ("GAO") published a report in which it identified ambulance provider costs per transport and...
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FDA Delays Food Maker Registration Renewals
October 10, 2012
Under the new Food Safety Modernization Act ("FSMA"), all food facilities that are required to register with FDA under section 415 of the Food, Drug, and...
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Lack of Funding Delays Implementation of Rules Under the FSMA
October 10, 2012
On October 1, 2012, FDA Commissioner Margaret Hamburg announced an additional delay involving the FSMA. She stated that the implementation of rules required by the FSMA...
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OIG to Release Updated Guidance on Exclusion Authority
October 9, 2012
OIG will release updated guidance on its exclusion authority within the next few months, according to the OIG's chief counsel, Gregory Demske. The new exclusion...
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OIG Report Finds that Structure/Function Claims on Dietary Supplement Labels Fail to Meet Federal Requirements
October 9, 2012
The OIG's report entitled "Dietary Supplements: Structure/Function Claims Fail to Meet Federal Requirements" analyzed structure/function claims that...
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Supreme Court Declines to Review Medical Device Preemption Case
October 8, 2012
On October 1, 2012, The Supreme Court denied a petition to review a decision by the United States Court of Appeals for the Fourth Circuit, which had affirmed that...
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OIG Releases 2013 Work Plan: Particular Focus on Provider Reimbursement and Claim Accuracy
October 8, 2012
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On October 3, 2012, the OIG published the agency's Work Plan for fiscal year 2013. The OIG announced that in the upcoming year it will investigate various Medicare...
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