Clinical Trial Transparency Biogen Joins the Center for Therapeutic Target Validation Thomas Sullivan Mar 11, 2016 0 The Center for Therapeutic Target Validation (CTTV) has a new member to boast about, helping them improve the success…
CMS CMS Proposed Rule Drastically Changes the Way Medicare Pays for Part B… Thomas Sullivan Mar 10, 2016 1 The Centers for Medicare and Medicaid Services announced their proposal to test new Medicare Part B prescription drug…
False Claims Act Amarin and FDA Off Label Free Speech Settlement Thomas Sullivan Mar 9, 2016 0 The United States Food and Drug Administration (FDA) and Amarin announced that they have reached a proposed settlement…
Medical Legal Endo New York Settlement Announcement Thomas Sullivan Mar 9, 2016 0 New York Attorney General Eric T. Schneiderman announced an agreement with Endo Health Solutions, Inc. and Endo…
Anti Kickback Tenet Healthcare Settlement Offer Thomas Sullivan Mar 9, 2016 0 Tenet has been locked in a legal battle against allegations that four of its hospitals violated the Anti-Kickback Statute and the…
FDA FDA Draft Guidance: Best Practices for Communication Between IND Sponsors… Thomas Sullivan Mar 8, 2016 0 To guide investigational new drug application (IND) sponsors' communication with the FDA during development phases, a…
Prescription Drug Prices New Indicators Show Prescription Drug Spending Increased Slower than… Thomas Sullivan Mar 7, 2016 0 We have been hearing for years now that the pharmaceutical industry is the reason for the spike in healthcare costs,…
Corporate Integrity Agreements Healthcare Company Boards Must Understand How to Manage Risk Thomas Sullivan Mar 4, 2016 0 In the Corporate Integrity Agreement (CIA) entered into by Olympus Corporation of the Americas, the Office of Inspector…
BioSimilar FDA Offering Free Biosimilars CME Course Thomas Sullivan Mar 4, 2016 0 There is a ballooning interest in biosimilars and interchangeable products in the pharmaceutical industry, especially…
Congress House Passes the Ensuring Terminated Providers are Removed from Medicaid… Thomas Sullivan Mar 3, 2016 0 The United States House of Representatives passed H.R. 3716, the "Ensuring Terminated Providers are Removed from Medicaid and CHIP…