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FDA
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…
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…
Forbes: FDA Overregulation of Off Label Promotion
The Food and Drug Administration (FDA) has acknowledged for years that "good medical practice and the best interests of the…
FDA: Bad Ad Program – How to Train Your Sales Rep
Often when we think of bad ads, things like the annoying Super bowl McDonalds Fish Filet Sandwich, or the Subway $5 dollar foot…
FDA Draft Guidance on Transparency and Advisory Committees
This week, Dr. Margaret A. Hamburg, Commissioner of the Food and Drug Administration (FDA), sent a letter to colleagues and staff…
PDUFA 2012 – Background From PhRMA’s Perspective
In 2012 Congress will be revisiting Prescription Drug User Fee Act (PDUFA). In an effort to prepare the FDA is asking for comments…
FDA – Proposed DTC Advertising Guidance – Clear, Conspicuous and Neutral
The Food and Drug Administration (FDA) has recently issued proposed guidance for direct to consumer television and radio ads as…
Building a Comparative FDA May Not Lead to Effectiveness
A recent article in the Journal of the American Medical Association (JAMA) discusses how to “Build Comparative Efficacy and…