Patient Selection For Analgesic Trials To Be Improved Under Public-Private ACTION Initiative
A new collaborative project between FDA and the University of Rochester could help drugmakers salvage pain drugs that have garnered negative clinical trial results but may have efficacy in a narrower population by creating more sensitive assays.
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Building on the Alzheimer’s disease Therapeutic Area Standard, the groups hope to create measurement standards for clinical trials in a variety of therapeutic areas, but funding remains an acute challenge. In order to succeed, each project needs to be faster and cheaper than the Alzheimer’s effort.
Label for duloxetine's new use emphasizes that efficacy was shown only in patients with chronic lower back pain and osteoarthritis.
Less than a year after signing a consent decree to resolve compliance problems, the company is forced to stop manufacturing its generic version of the best-selling cholesterol drug. For FDA, the issue poses a public relations challenge since it touches on several areas where the agency has recently been criticized – generic drug quality, manufacturing oversight and drug shortages.