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Life Science Compliance Update
Like Taxes and Inflation – HHS Revises Civil Monetary Penalties…
The Department of Health and Human Services has issued an Interim Final Rule, adjusting for inflation the maximum civil monetary…
BMS Settles with California Insurance Commission – Seems Everyone Is…
Life sciences companies continue to be the target of whistleblower actions, not only on the federal level but the state level as…
How Realistic is the Yates Memo after Acclarent?
There has been much hubbub around the Yates Memorandum and what it means for compliance officers, especially in the life sciences…
Opioids Under the Microscope – A Recap of Recent Events that Could…
Opioids are under the microscope by a variety of groups, including political and pharmaceutical organizations. Now, adding fuel to…
EFPIA HCP Financial Disclosure Is Not Risk Free
A large number of pharmaceutical companies across Europe had until June 30, 2016 to disclose their financial interactions with…
What You Don’t Know About AMP Can Hurt You – Part 3 Can You Defend…
As part of a three-part series on the Average Manufacturer Price (AMP), this month’s article explores the continuing and evolving…
Getting to the Hub of the Matter: Analyzing the Compliance Needs for Hub…
Within the pharmaceutical industry there are new operating models emerging. One form of emerging arrangement is the increasing use…
AseraCare – Even Courts Seek Second Medical Opinions
In the AseraCare case, the United States Department of Justice (DOJ) sought to show that AseraCare submitted false claims. Relying…
As If the DOJ Weren’t Enough – Shareholders Are Increasingly Quick to Sue…
Recent plaintiff wins in lawsuits against life sciences companies seeking to recover lost shareholder value resulting from…
State of the European Union – Transparency in Europe 2016 and Beyond
Three years ago, EFPIA adopted the EFPIA transparency code. Now three years later, this article takes the opportunity to look at…