This article was originally published in The Gray Sheet
Executive SummaryFirms sign letter of intent under which Visx "for a negotiated fee" will make use of Alcon's "resources and expertise" to guide a voluntary review of Visx clinical investigative sites. FDA recently sent Form 483 inspectional observation reports to two of Visx's 26 investigative sites ("The Gray Sheet" Sept. 12, p. 13). However, Visx maintains that its decision to conduct the independent reviews "was neither requested nor required by the FDA." The agreement also calls for Alcon to provide further "regulatory services" to Visx "on an ongoing basis." In addition, Visx announces that Alcon Chairman, CEO and President Edgar Schollmaier will rejoin Visx' board of directors; Schollmaier served on the Visx board from 1987 to 1993
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