This bill requires the Food and Drug Administration (FDA) to inform generic drug applicants, upon request or during review, whether the drug is qualitatively and quantitatively the same as the listed brand-name drug (and if not, the reasons why). The FDA must also update or publish guidance on how it makes such determinations.
Became Public Law No: 119-75.
Read twice and referred to the Committee on Finance.
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, the Budget, the Judiciary, and Education and Workforce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
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