ICMEJ Proposes Data Socialism – Data Utopianism Has its Cracks –…
The International Committee of Medical Journal Editors (ICMJE) recently put forth a proposed set of new requirements for…
Monthly Publications
In Depth
Subscribe Now
In Depth
coverage of timely
Life Science
Compliance issues
Subscribe Now
Yearly Archives
2016
European Medicines Agency: Framework for Interaction with Industry
The European Medicines Agency's (EMA) Management Board has adopted a new framework to govern interaction between the…
DOJ Becoming Comfortable With Permitting Truthful, Non-misleading Promotion
As we know all too well, the U.S. Food and Drug Administration (FDA) has long taken the position that a medical device…
ProPublica HIPAA Helper or HIPAA Wall of Shame
ProPublica, the same organization who brought us "Dollars for Docs" and the "Surgeon Scorecard," is once again making a…
Another Transparency Threat – Health Education Exchanges and Medical…
We have previously drawn attention to some of the downsides of transparency as it relates to medical information. Those…
FDA CDER Update 2016
We recently reported that 2015 resulted in the highest level of newly approved U.S. drugs in nineteen years. This…
Senators Wyden and Grassley Request Public Comments on Gilead Pricing
On the heels of their December 1, 2015, report on Gilead Sciences' pricing of Hepatitis C drugs Sovaldi and Harvoni,…
CMS Final Rule on Covered Outpatient Drugs
The Centers for Medicare & Medicaid Services (CMS) issued the Covered Outpatient Drugs final rule with comment on…
Office of Management and Budget To Revise Fraud Rules by Spring
The White House Office of Management and Budget released their 2016 rule agenda at the close of last year, laying out…
Improving Regulatory Transparency for New Medical Therapies Act
President Obama recently signed the Improving Regulatory Transparency for New Medical Therapies Act into law. The Act…