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Home » FDA Issues New Guidance on Updating Labeling for Generics After Revisions to Reference Drug Labels
FDA Issues New Guidance on Updating Labeling for Generics After Revisions to Reference Drug Labels
The FDA has released draft guidance for applicants and holders of an abbreviated new drug application (ANDA) on updating their labeling after revisions to the approved labeling of a reference listed drug (RLD) on which a generic drug is based.