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Speaking at the Generic Drugs Forum, Darby Kozak, deputy director of the Office of Generic Drugs, also highlighted the passage of the Consolidated Appropriations Act, 2026, which requires FDA to discuss with applicants whether their drug is qualitatively (Q1) and quantitatively (Q2) the same as the reference listed drug, and if not, to provide details about why the drug was determined not to be qualitatively or quantitatively the same

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