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Labels: FDA
posted by The Medicine Man at 9:22 PM
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Since early 2004, I have been a full-time assistant professor at the UCLA School of Medicine. I work primarily in the General Internal Medicine Division at Harbor-UCLA Medical Center (a large county medical facility). Currently, I teach medical students, interns and residents in our program and am involved in a number of academic projects.
I have been in private practice with several multispecialty groups and have worked as a hospitalist both for a group and as a solo practitioner before assuming my current position at UCLA.
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1 Comments:
Since the enactment of PDUFA, the FDA approval process has an inherent conflict of interest - pharmaceutical companies pay “user fees” to the FDA. A recent NEJM article indicates that such fees may come to approximately $300 million or 18 percent of the current total FDA budget (which would translate to a higher percentage of the drug evaluation budget).
Since studies are not very reliable predictors of the safety of a drug after it comes to market, a much better postmarketing surveillance system is urgently needed.
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