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The process of transferring analytical methods from research labs to commercial labs is fraught with challenges and biotech manufacturers must pay careful attention to everything in the transfer process, especially for overseas transfers. A diverse toolkit is needed to test these complex molecules. An increasing number of product launches is putting pressure on biotech manufacturers to complete these tech transfers quickly, and industry is receiving little guidance from FDA.
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GAO's 'high risk' report lowers FDA grade for its drug shortage action plans, saying efforts have not been sustained.
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