To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications.
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.
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{# E23 (Nick, ruling section 1 answer 10): quoting a bill or a court opinion works
the way quoting a news article works. Select a passage above and the same panel
opens: the passage goes to the official you choose, with this document's own
address as its source and its own type. #}