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Life Science Compliance Update
TEVA – Using Legitimate Distributor Payments to Conceal Bribes
On December 22, 2016, the Securities and Exchange Commission (SEC) announced that Teva Pharmaceutical Industries Limited had…
Going Back to the Roots of the False Claims Act – Baxter Settles cGMP…
While False Claims Act cases are relatively common in the life science industry, FCA cases for cGMP violations are not. This…
Project Exclusion: The OIG’s Latest Attempt to Make Its Exclusion Authority…
On January 11, 2017, the Office of Inspector General (OIG) at the U.S. Department of Health and Human Services (HHS), issued a new…
Healthcare Reform – Chinese Style
Amy Greenstein, Senior Consultant and Dana Liu, Consultant, Polaris
The PRC continues to focus on three principle life science…
340B and You: Thoughts on Program Oversight for Pharmaceutical…
The 340B Drug Discount Program plays an important role in the United States healthcare system by providing healthcare services…
A Last Hurrah as CDRH Issues Guidances Before Obama’s Departure
In a last-minute attempt to put a permanent mark on the life sciences (and specifically, the medical device) industry, the…
Using the Crystal Ball: What Does the Future Hold for Life Science…
Recently, as part of the course Legal Compliance Essentials for Drug, Device and Biotech Companies, Mitchell Hamline Law…
Accountability: The shifting landscape of compliance responsibilities
The meaning of effectiveness of healthcare compliance programs has shifted in recent years. This article examines that…
Privacy Regulation: The Final Frontier of Life Science Compliance
Recently, as part of the course Legal Compliance Essentials for Drug, Device and Biotech Companies, Mitchell Hamline…
FDA’s Meeting on Promotion – Can We Glimpse the Future?
In November, the FDA held a two-day Town Hall meeting to allow for input from stakeholders and patients surrounding…