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FDA’s focus on the quality culture and its request for quality metrics may ensure a successful company-CMO relationship.
As Naheed Sayeed, Ajay Pazhayattil and Jena Spes of Apotex write, FDA’s guidances on quality agreements and quality metrics came at just the right time to address ongoing issues. Both guidances should benefit the industry, but, above all, the consumer, by establishing a framework for developing a culture of quality.
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