Medical Legal Former Sanofi Paralegal Brings $34 Million Whistleblower Lawsuit Thomas Sullivan Dec 11, 2014 0 A paralegal recently fired by French drug manufacturer Sanofi has filed a whistleblower lawsuit, claiming she was discharged after…
Uncategorized New Bill Would Exempt Low-Risk Medical Software and Apps from FDA… Thomas Sullivan Dec 10, 2014 0 Bipartisan legislation drafted by Senators Orrin Hatch (R-Utah) and Michael Bennett (D-Colo.) looks to exempt electronic health…
FDA FDA Combination Product Classification Again Struck Down By D.C. Court Thomas Sullivan Dec 9, 2014 0 Whether the FDA considers a product to be a “medical device” as opposed to a “drug” has very important implications.…
Open Payments Resources Physician Payments Sunshine Act: List of Open Payments Resources Thomas Sullivan Dec 8, 2014 0 2014 has been a big year for the Physician Payments Sunshine Act. Applicable manufacturers submitted their 2013 payment data in…
Quality Improvement National Quality Forum Begins Annual Review of Quality Measures, Comments… Thomas Sullivan Dec 5, 2014 0 On Monday, the Measure Applications Partnership (MAP) began its annual review of performance measures that the Centers…
Open Payments Open Payments Search Tool Now Includes Summary Information about Companies… Thomas Sullivan Dec 4, 2014 0 The Centers for Medicare and Medicaid Services (CMS) today made a number of announcements related to the Open Payments…
CME 2014 IACE Survey Offers Benchmarking Insights Into Commercial Support of… Thomas Sullivan Dec 4, 2014 0 The Industry Alliance for Continuing Education's (IACE) Benchmark Work Group (BWG) have shared their 2014 study of the life…
DOJ Vascular Solutions Inc. and its CEO Charged with Selling Unapproved… Thomas Sullivan Dec 3, 2014 0 Last month, the Department of Justice filed an indictment charging Vascular Solutions Inc. and its chief executive officer, Howard…
Innovation A Tough Road: Cost To Develop One New Drug Is $2.6 Billion; Approval Rate… Thomas Sullivan Dec 2, 2014 3 Developing a new prescription medicine that gains marketing approval is estimated to cost drugmakers $2.6 billion according to a…
DOJ DaVita Reaches $350 Million Settlement Over Dialysis Center Referrals Thomas Sullivan Dec 1, 2014 0 DaVita, a leading dialysis services provider, has agreed to one of the largest healthcare settlements of 2014. The Department of…