S.1302

Increasing Transparency in Generic Drug Applications Act amends the Federal Food, Drug, and Cosmetic Act to enhance transparency in generic drug.

The Increasing Transparency in Generic Drug Applications Act amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to issue guidance on determining whether a drug is qualitatively and quantitatively the same as a listed drug. This includes assessing pH adjusters. The Secretary must publish draft guidance, allow a 60-day comment period, and finalize the guidance within a year.