Bill > HR2455

This bill aims to advance precision medicine by amending the Federal Food, Drug, and Cosmetic Act. It requires the Food and Drug Administration (FDA) to define what constitutes a "precision drug or biological product," which are treatments tailored to patients likely to respond based on specific biological characteristics like genetic factors, often referred to as biomarkers. The FDA will also issue and update guidance on how to use these biomarkers to identify patient subsets that will benefit most from a medication, including recommendations for study design and how biomarkers can influence the assessment of a drug's benefits and risks. Furthermore, for precision drugs or biological products intended for serious or rare conditions, the FDA may allow the use of previously submitted data from other approved medications or indications to speed up the development process, and these applications may be eligible for expedited review.