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FDA Criticized for Moving Too Slowly
The Food and Drug Administration (FDA) is a frequent target of Congressional critics, sometimes for good reason. Earlier this…
ClinRegs Upgrades Are Here!
Longtime readers may remember when the National Institute of Allery and Infectious Diseases (NIAID) released the ClinRegs website,…
FDA Announces Dates for Public Hearing on Off-Label Communication…
In late August, the United States Food and Drug Administration (FDA) announced that it will hold a two-day public hearing November…
Novartis CEO Predicts Shift in Drug Pricing, Post-Election
In an interview with the Financial Times, Joe Jiminez, CEO of Novartis, predicts that November’s election may “trigger a sea…
Mylan CEO Under Fire at House Hearing
Two weeks ago, in the midst of the hubbub surrounding Mylan and its EpiPen, Jason Chaffetz and Elijah Cummings, Chairman and…
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…
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…
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…
ABIM and ACCME Expand Collaboration
The American Board of Internal Medicine (ABIM) and the Accreditation Council for Continuing Medical Education (ACCME) have…