FDA Offers Update to Orange Book Website
In August 2016, the Food and Drug Administration (FDA) launched an updated web-based version of its “Orange Book,” the publication…
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Yearly Archives
2016
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…
PDUFA IV: Full Steam Ahead?
On July 15, 2016, the Food and Drug Administration (FDA) released a forty-six page document outlining how the FDA will use the…
Legislation Introduced to Modify Hospital Quality Star Ratings Release
We have previously covered another of CMS’ transparency initiatives—its hospital star ratings—and some of the concerns industry…
On a Collision Course – FDA Clinical Investigator Disclosure and Open…
FDA’s requirements for clinical investigator d closure and the Open Payments requirements are at odds in many ways. This article…
New Rule and Guidance Issued on Clinical Trials
Clinical trials are one of the most visible components of the biomedical research field, in part due to the way they directly…
Webinar – Next Generation Compliance: Using Analytics to Reduce Compliance…
On Tuesday, September 20, 2016, at 11:00 am EDT, qordata is hosting a webinar on how to use analytics to reduce compliance risks.…
Mylan Pricing Summary: A Case Study in Increases
We’re only a few months removed from the constant news about Martin Shkreli and Valeant Pharmaceuticals and their price hikes on…
New OIG Guidance on IRO Independence and Objectivity
In August 2016, new Health and Human Services (HHS) Office of Inspector General (OIG) guidance was issued on Independent Review…
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…