> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Meeting on Drug Development Tool Process
- URL: https://www.fdaweb.com/meeting-on-drug-development-tool-process/
- Published: 2018-11-12T12:00:00.000Z
- Updated: 2026-09-15T00:43:59.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5142792

*Federal Register* notice: FDA has announced a 12/11 public meeting entitled “Drug Development Tool Process under the 21st Century Cures Act and PDUFA VI.” The meeting is intended to fulfill commitments made under the recently reauthorized Prescription Drug User Fee Act and the 21st Century Cures Act by soliciting comments on drug development tool (DDT) qualification. It will discuss and seek public input regarding the DDT qualification pathway for animal models, biomarkers, and clinical outcome assessments. The meeting will also describe the scientific criteria to determine the acceptance of a qualification submission and essential elements of a full qualification plan. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-11-13/pdf/2018-24656.pdf?ref=fdaweb.com).