CMS: Hospital and Critical Access Hospital (CAH) Changes to Promote…
CMS recently released a proposed rule updating the Conditions of Participation (CoP) for 6,228 hospitals and critical access…
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June 2016
How the FDA Is Doing with Medical Devices and the Medical Device Industry
The FDA and the GAO both released data on the FDA's performance in medical device regulation over the last several years. This…
Carl Reichel Warner Chilcott Executive Acquittal Deals Blow to Yates Memo
In a blow to the Department of Justice and the Yates Memo, a Massachusetts jury acquitted Warner Chilcott executive Carl Reichel.…
GAO Report Harshly Critical of Medicare Advantage Plans
A May 2016 report from the United States Government Accountability Office (GAO) is harshly critical of Private Medicare Advantage…
PhRMA Members Invested $58.8 Billion in R&D in 2015
In 2015, PhRMA member companies invested $58.8 billion in research and development, up 10.3% from 2014. The new R&D data is…
Sun Pharma Receives Grand Jury Summons
Sun Pharmaceuticals, India's largest drug maker, recently disclosed that the United States Department of Justice (DOJ) has…
Detecting the “Sham” in Speaker Programs
In late March 2016, Novartis Pharmaceuticals Corp. (NPC) and the U.S. Department of Justice and the State of New York…
Ex-Pharma Sales Staff Arrested on Anti-Kickback Charges
It was recently announced that Jonathan Roper, a former District Manager at Insys Therapeutics, and Fernando Serrano, a…
FDA Issues Guidance on Expanded Access to Investigational Drugs
The United States Food and Drug Administration (FDA) has recently issued guidance in response to a request in the 21st…
Salix Settlement Approved
On Thursday, June 9, 2016, United States District Court Judge Denise L. Cote approved a settlement stipulation to…