Here are a few versions describing the Prescription Drug User Fee Act [PDUFA] [1] Wikipedia [2] FDA [3] PhRMA. Essentially it’s a deal between PhRMA and the FDA. The drug manufacturers pay when they register an NDA [New Drug Application], and in return, the FDA uses the money to speed up the evaluation process. It […]
What Happens When Underperforming Big Ideas in Research Become Entrenched? by Michael J. Joyner, Nigel Paneth, and John P. A. Ioannidis JAMA. published online 07/28/2016. [full text on-line] For several decades now the biomedical research community has pursued a narrative positing that a combination of ever-deeper knowledge of subcellular biology, especially genetics, coupled with information technology will lead […]
"During this growing time of behavioral healthcare, the State of Recovery Conference will bring together treatment providers from the substance abuse, mental health and eating disorder community nationwide and provide a focus on the business side of the behavioral healthcare including treatment center startup, revenue growth and total treatment program efficency…" "The substance abuse treatment […]
NIH names Dr. Joshua Gordon director of the National Institute of Mental Health National Institute of Health July 28, 2016 National Institutes of Health Director Francis S. Collins, M.D., Ph.D., announced today the selection of Joshua A. Gordon, M.D., Ph.D., as director of the National Institute of Mental Health [NIMH]. Dr. Gordon is expected to […]
At this summer’s American Psychiatric Association meeting, Karen Dineen Wagner, president elect of the American Academy of Child and Adolescent Psychiatry discussed the treatment of depressed children and adolescents, saying: …only two drugs are approved for use in youth by the Food and Drug Administration [FDA]: fluoxetine for ages 8 to 17 and escitalopram for […]
Note: I am pleased to announce that Google has moved me from This site may have been hacked to This site is not mobile friendly status. I see this as a real step up in the world and will look into the mobile friendly issue the next time I’ve got nothing else to do. I […]
So Charlie Chaplin tried to warn us about technology in his 1936 classic, Modern Times. The french philosophers Jean-Paul Sartre, Simone de Beauvoir and Maurice Merlau-Ponty even named their journal, Les Temps modernes, after the film. But neither Chaplin nor the Existentialists warned us about this… While the site was operating normally, this message appeared […]
"Another issue with pediatric clinical trials is that 61 percent of youth respond to the drugs, but 50 percent respond to placebo, compared with 30 percent among adults, making it hard to separate effects." Karen Dineen Wagner in Child Psychiatrists Look at Specialty From Both Macro, Micro Perspectives The Placebo Effect in Clinical Trials is […]
early days… Practicing as an Internist in a Military Hospital back when the world was young, fresh out of a residency training program, I had a period I think of as on-the-job training. I learned that the majority of patients referred to me as an Internist didn’t have medical diseases. They had some kind of […]