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FDA
FDA Direct to Consumer Proposed Rule: Advertising Coalition’s Response
The Advertising Coalition recently sent comments to the Food and Drug Administration (FDA) in response to a Notice of Proposed…
FDA Turns to CME for Risk Evaluation and Mitigation Strategy (REMS) Pain…
According to a FDA memo and recent article in the RPM Report, “continuing medical education (CME) has been under attack in…
FDA – PDUFA Monthly Meetings Beginning July 1, 2010
The statutory authority for the Prescription Drug User Fee Act (PDUFA) is set to expire in September 2012. At that time, new…
FDA Proposed Rule on Falsification of Data
For years, the Food and Drug Administration (FDA) has acknowledged that “falsification of data can, if not detected, undermine…
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…