Guidance for Industry - Pharmacogenomic Data Submissions

The information collection supports agency guidance. Respondents to the collections are sponsors holding Investigational New Drug Applications (INDs), New Drug Applications (NDAs), and Biologics License Applicatons (BLAs). The guidance makes recommendations to respondents with regarding what pharmacogenomic data to submit to FDA during the drug development process, the format of submissions, and how the data will be used in regulatory decisionmaking.

The latest form for Guidance for Industry - Pharmacogenomic Data Submissions expires 2020-09-30 and can be found here.