Sailing with a New Safe Harbor in Sight: The EU-U.S. Privacy Shield
Beginning August 1, 2016, the United States Department of Commerce began accepting self-certifications to the EU-U.S. Privacy…
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FDA Issues Guidance on REMS
With the passage of the long-awaited 21st Century Cures legislation, we saw Senator Mike Lee (R-UT) vote “no” because the bill did…
Managing Medical Inquiries in an Era of Data Analytics
Although compliance professionals tend to view Corporate Integrity Agreements (“CIAs”) as setting the basic compliance standards,…
President-Elect Donald Trump on the Pharmaceutical Industry
On Wednesday, January 11, 2017, President-Elect Donald Trump held a news conference in New York; a conference that was held out…
HHS Releases Regulations on Alternative Pay Models in Last Weeks of Current…
Despite Republicans’ call for a suspension on new rules, the Department of Health and Human Services (HHS) pushed regulations…
Maintaining Independence & Objectivity – OIG Releases New IRO…
The Health and Human Services Office of Inspector General has released new guidance on an important topic, Independent Review…
FDA Seeking Comments on Direct to Consumer Advertising Proposed Research
On January 4, 2017, the United States Food and Drug Administration (FDA) published a Notice in the Federal Register, requesting…
OIG Report Addresses High Federal Spending on Catastrophic Part D Coverage
The Department of Health and Human Services (HHS) Office of Inspector General (OIG) today released a report examining federal…
Feeling Needy: The Why, What and How of Needs Assessments
Given trade association guidance and recent government involvement in life sciences transactions, this article emphasizes the…
A Review of CMS’ Hospital Compare Website
As we reported, in July CMS released its first-ever hospital quality star ratings on its Hospital Compare website. The overall…