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FDAnews Drug Daily Bulletin
Nov. 1, 2012 | Vol. 9 No. 215
Mexico Taking Closer Look at Clinical Trial Protocols, Doubling Review Times
Mexican drug regulator Cofepris has doubled its clinical trial protocol review timeline, with approvals coming in six months now instead of three, an expert says. The addition of three months comes as the number of foreign clinical trials has begun to boom in Mexico, with more trials being conducted at smaller clinical sites, Rosalinda Mondragon, investigational product manager at Sanofi-Aventis Mexico, said.
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