VISX TO HIRE INDEPENDENT FIRM FOR REVIEW OF CLINICAL TRIAL SITES
This article was originally published in The Gray Sheet
Executive SummaryVISX TO HIRE INDEPENDENT FIRM FOR REVIEW OF CLINICAL TRIAL SITES in response to "concerns" expressed in FD-483 inspectional observation reports sent by FDA to two of the company's clinical investigative sites, the company said in a Sept. 7 teleconference. The review is voluntary and designed "to assure that ongoing clinical investigations are being conducted in compliance with regulatory requirements," the company said.
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