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.

Source: Congressional Research Service (CRS).