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The QMN Weekly Bulletin
Jan. 20, 2012 | Vol. 4 No. 3
FDA May Issue More Guidance on Outsourcing Responsibilities
Concerned about the upward trend in supplier quality issues, the FDA is considering agency-wide guidance to clarify manufacturers’ responsibilities for outsourcing, an agency official says. The FDA sees the need for more clarity on its expectations for manufacturers using contract manufacturing organizations, Rick Friedman, associate director in CDER’s Office of Manufacturing & Product Quality, said.
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