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…
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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…
Astra Zeneca Seroquel Settlement and Corporate Integrity Agreement
Under the Food, Drug and Cosmetic Act, a company must specify the intended uses of a product in its new drug application to the…
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…
FDA Educates Industry on Development of Orphan Drugs
In the complex and expensive world of research and development for drugs, there are therapies for conditions known as “orphan…
GAO Recommends the FDA to Strengthen Investigation Oversight
Within the Food and Drug Administration (FDA) is the Office of Criminal Investigations (OCI), which investigates individuals and…
Fox Stossel Show: Hands Off My Healthcare
Tonight at 8:00pm and 11:00pm EST on the Fox Businesses Channel, John Stossel, host of "Stossel" on the Fox Business…