Exploring Strage New Worlds – FDA’s 2016 Program Alignment and…
This article provides an overview of the FDA's initiative to realign programs from location-centered structures and…
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FDA ER-LA REMS Day One of Meeting of the Drug Safety and Risk Management…
The Food and Drug Administration (FDA) is hosting a two-day long Joint Meeting of the Drug Safety and Risk Management…
CBI Forums on Transparency & Aggregate Spend
The Annual Forums on Transparency and Aggregate Spend are coming up. The 7th Annual West Coast Forum on Transparency…
Pfizer/Wyeth Settlement Finalized and Signed: States Net Millions
The Department of Justice ("DOJ") recently entered into a settlement of a quit tam lawsuit against Pfizer, Inc. and…
Peeling Back the Olympus Onion – The Importance of Culture
This article examines an apparent breakdown in corporate culture that goes beyond the subsidiaries to the parent…
IMS Releases 2016 Report on Prescription Drug Spending – Net Price Growth…
The IMS Institute for Healthcare Informatics released its annual Medicines Use and Spending in the U.S. report.…
Do Gold-Standard CIAs Get Blue Ribbon Approval?
Corporate Integrity Agreements are thought to set the standard for compliance programs, but when viewed against the norms…
Medicare Access and Chip Reauthorization Act (MACRA) Proposed Rule, MIPS,…
The Centers for Medicare and Medicaid Services (CMS) released its proposed 962 page rule for the Medicare Access and…
US Senate Committee on Homeland Security, Hearing: America’s Insatiable…
Prescription drugs have been in the news for months: pricing issues, transparency problems, and the presidential…
Tick-tock – The Role of Compliance in M&A
activities In this article, we review advice from industry thought leaders on (1) how to ensure compliance officers are a part of…