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…
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FDA
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…
Letters from Grassley: FDA to Clarify Policies on Medical Devices
This week, Senator Charles Grassley (R-IA), ranking member of the Senate Finance Committee, issued a press release asking the Food…
Five Part Podcast Series on FDA Features John Kamp of Coalition for…
A new five-part Podcast series was recently announced by Med Ad News editors Steven Niles and Joshua Slatko. The series will…
FDA Official Cleared of Conflict Allegations in Heparin Contamination Case
Last week Janet Woodcock, director of the Center for Drug Evaluation and Research at the FDA was cleared of a conflict of interest…