Congress Testy Oversight and Government Reform Committee Hearing on Prescription… Thomas Sullivan Feb 5, 2016 0 The United States House Oversight and Government Reform Committee held a hearing on developments in the prescription…
CMS Physician Payment Sunshine Act: Open Payments Final 2015 Data Submission… Thomas Sullivan Feb 4, 2016 0 In our latest endeavor to try to help you wade through the lengthy regulations known as Open Payments leading up to the…
Open Payments Open Payments Question & Answer Session on February 9, 2016 Thomas Sullivan Feb 4, 2016 0 Centers for Medicare and Medicaid Services is hosting an informal Question and Answer session on February 9, 2016, from…
Clinical Research ICMEJ Proposes Data Socialism – Data Utopianism Has its Cracks –… Thomas Sullivan Feb 3, 2016 0 The International Committee of Medical Journal Editors (ICMJE) recently put forth a proposed set of new requirements for…
International European Medicines Agency: Framework for Interaction with Industry Thomas Sullivan Feb 2, 2016 0 The European Medicines Agency's (EMA) Management Board has adopted a new framework to govern interaction between the…
DOJ DOJ Becoming Comfortable With Permitting Truthful, Non-misleading Promotion Thomas Sullivan Feb 1, 2016 0 As we know all too well, the U.S. Food and Drug Administration (FDA) has long taken the position that a medical device…
Transparency ProPublica HIPAA Helper or HIPAA Wall of Shame Thomas Sullivan Jan 29, 2016 0 ProPublica, the same organization who brought us "Dollars for Docs" and the "Surgeon Scorecard," is once again making a…
Electronic Health Records Another Transparency Threat – Health Education Exchanges and Medical… Thomas Sullivan Jan 29, 2016 1 We have previously drawn attention to some of the downsides of transparency as it relates to medical information. Those…
FDA FDA CDER Update 2016 Thomas Sullivan Jan 28, 2016 0 We recently reported that 2015 resulted in the highest level of newly approved U.S. drugs in nineteen years. This…
Congress Senators Wyden and Grassley Request Public Comments on Gilead Pricing Thomas Sullivan Jan 27, 2016 0 On the heels of their December 1, 2015, report on Gilead Sciences' pricing of Hepatitis C drugs Sovaldi and Harvoni,…