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.
Referred to the Subcommittee on Health.
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Placed on Senate Legislative Calendar under General Orders. Calendar No. 108.
Motion to reconsider laid on the table Agreed to without objection.
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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