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BioWorld - Wednesday, May 18, 2022
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Home » FDA combo products guidance offers more flexibility for cross-labeling
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FDA combo products guidance offers more flexibility for cross-labeling

Jan. 31, 2022
By Mark McCarty
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U.S. FDA regulation of combination products has always been complicated, and a new final guidance takes up the long-standing controversy over FDA review of these applications. The final guidance makes explicit the possibility that the individual components of a cross-labeled combination product will be reviewed separately, a concession that industry saw as critical to ensure that these applications can make it through the FDA gauntlet without undue delay.
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