Risk Evaluation and Mitigation Strategies (REMS) Summary
According to a recent assessment by the Tufts Center for the Study of Drug Development (CSDD), “drug developers, healthcare…
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IRS Releases Proposed ACA Fee Structure for Pharmaceutical Medical Device…
With implementation of the new device tax two years away, the Internal Revenue Service (IRS) is trying to determine which devices…
University of Miami Business Forum: The Business of Healthcare –…
The University of Miami Schools of Business and Medicine held the University of Miami Global Business Forum. The event, entitled…
FDA Boot Camp — Hooah
As the regulatory landscape for pharmaceutical and medical device companies continues to rapidly change, and as key provisions of…
Florida Court Overturns Affordable Care Act – The Whole Thing, On the Road…
Today, United States District Judge Roger Vinson ruled that the entire health care overhaul is unconstitutional, but he stopped…
ProPublica Intimidates Denver Area Hospitals and Medical Schools
The latest victim to fall to the irresponsible and questionable journalistic practices of the Pew funded ProPublica was the…
FDA Seeks Input on Transparency Initiative
In June 2009, Food and Drug Administration (FDA) Commissioner Dr. Margaret Hamburg launched FDA’s Transparency Initiative to help…
The Reimbursement Landscape for Novel Diagnostics: Current Limitations,…
The Biotechnology Industry Organization (BIO) recently released a report entitled, “The Reimbursement Landscape for Novel…
JAMA: Continuing Medical Education Improves ICU Patient Care
When patients experience severe and debilitating diseases or undergo critical procedures, they are often hospitalized in the…
President to Improve Regulation and Regulatory Review to Spark Innovation
In the State of the Union along with a commentary published in the Wall Street Journal last week, President Obama laid out his…