Medical Product Development Resources


Drug Development Overview

Drug Development Tools (DDTs)

  • DDTs are methods, materials, or measures (such as animal models, biomarkers, clinical outcome assessments, etc.) that can potentially facilitate drug development. More information and resources on FDA established qualification programs to support DDT development can be found on the link below

    Drug Development Tools | DDTs

  • Development and approval process review by FDA Center for Biologics Evaluation and Research (CBER)

    Development & Approval Process (CBER)