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Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced April 3, 2025 by Margaret Wood Hassan · Last progress 11 months ago
Requires the Department of Health and Human Services (FDA) to tell a generic drug applicant whether their proposed product is "qualitatively and quantitatively the same" as the listed (brand) drug and to identify any inactive ingredients and amounts that differ. The agency must issue guidance within one year explaining how those sameness determinations will be made (including how pH adjusters are treated) and must allow public comment on that guidance; the rules take effect on enactment.