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"Much of the future impact of the regulations on research will depend on just how wisely the Food and Drug Administration administers them." James D. Gallagher, MD, director of Medical Research at Lederle Laboratories, told the American College of Neuropsychopharmacology in Washington, DC, Jan 16.
"We are currently in a period of transition," Gallagher said, and although it is an uncertain situation, it is a hopeful one. In order to get at the real problems facing the pharmaceutical industry and the research community, we must accept certain facts and realize that some of them for the moment appear immutable."
First, recent regulatory events have made it clear that government, industry, and the community of clinical investigators are in business together. "At least for a time it appeared to us that there was an unwillingness of government and the investigator to recognize each other's presence in this problem. In the
Drug Industry Situation Uncertain But Hopeful. JAMA. 1964;187(11):35. doi:10.1001/jama.1964.03060240109061
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