Affordable Care Act and Biotech’s Adjusting to the New Landscape
After the passage of the Affordable Care Act (ACA) in March, the biotechnology-industry began to focus on a number of measures…
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Physician Payment Sunshine: Medtronic Reports Physician Payments
Following the trend of major pharmaceutical companies such as Pfizer, Eli Lilly, Merck, and GlaxoSmithKline, medical-device maker…
Tufts Study Shows Clinical Trials Are Harder To Conduct
The Tufts Center for the Study of Drug Development (CSDD) at Tufts University provides strategic information to help drug…
PACME: Session on External Environment Looked 360
I recently had the opportunity to moderate a panel at Pharmaceutical Alliance for Continuing Medical Education (PACME) discussing…
Research America Study: American’s Confident in FDA and Biomedical Research
Before taking your next insulin shot or beta blocker, did you ever wonder how the medication your taking went from the labs into…
FDA: Off Label May Be the Wrong Label
The Food and Drug Administration (FDA) has acknowledged for years that "good medical practice and the best interests of the…
AMA CEJA: Strike 4 – Report Perhaps Ushered from the CME Ballpark
In its fourth attempt to soil independent CME grants provided by industry to advance competency and patient outcomes, the…
IOM: Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease
In 2008, the Food and Drug Administration (FDA) asked the Institute of Medicine (IOM) to conduct a study on the evaluation…
FDA Transparency Initiative: Draft Disclosure Policies
In addition to the recently published Nation Institutes of Health (NIH) transparency Guidelines, the Food and Drug Administration…
NIH Proposed Transparency Rules
The National Institutes of Health (NIH) proposed new rules to amend its regulations on the Responsibility of Applicants…