Home » FDA Finalizes Requirements for Drug Development Tools Qualification Process
FDA Finalizes Requirements for Drug Development Tools Qualification Process
December 7, 2020
The FDA yesterday issued a final guidance outlining the process for sponsors and researchers to submit plans for new drug development tools (DDT) to the agency for approval.
The agency’s DDT qualification program reviews biomarker, clinical outcomes assessment and animal model tools to be used in clinical trials. If accepted — or “qualified” — the tools can be used by the developer or other researchers in future trials without seeking prior FDA approval.
The guidance is virtually unchanged from the draft issued in December 2019, which divides the qualification process into three stages (CenterWatch Weekly, Dec. 15, 2019). The applicant first submits a letter of intent that describes the scientific rationale for the tool. If after a three-month review, the FDA accepts the letter, the applicant submits a qualification plan that includes all basic information about the tool, which the agency also will take three months to review. If invited by the agency, the applicant submits a full qualification package that includes detailed descriptions of all studies, analyses and results requested by the FDA. The final review stage takes 10 months.
Examples of FDA-qualified DDTs and definitions are listed in the Biomarkers, Endpoints and other Tools (BEST) glossary, created and regularly updated by the FDA-NIH Biomarker Working Group.
