Increasing Transparency in Generic Drug Applications Act

This bill requires the FDA to provide generic drug manufacturers with specific, written disclosures about whether their proposed drug formulation matches the reference drug's inactive ingredients in both type and concentration. If differences exist, the FDA must identify the specific ingredients and quantify any deviations. The bill also mandates that the FDA issue guidance within one year on how it will assess formulation similarity, including a 60-day public comment period. These requirements apply immediately upon the bill's enactment to all generic drug applicants seeking approval under Section 505(j).