This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to define "precision drug or biological product." (Precision medications are commonly understood to be treatments for those patients who are likely to respond to the medication based on a biomarker, which is a biological characteristic such as a genetic factor.)
The FDA must issue and periodically update guidance that addresses the development and use of biomarkers to identify the subset of patients that are likely to respond to a medication.
The FDA may rely upon data previously submitted for a different approved medication or indication to expedite the clinical development of a precision medication that has been designated for the treatment of a serious or rare condition.