The U.S. Food and Drug Administration (FDA) recently released a final guidance detailing the process for sponsors and clinical researchers to submit plans for new drug development tools (DDTs) for agency approval.
“Effective, unambiguous communication is essential for efficient translation of promising scientific discoveries into approved medical products,” says the FDA-NIH Biomarker Working Group in the collection of FDA-qualified DDTs and definitions it has listed in a Biomarkers, Endpoints, and other Tools (BEST) glossary. “Unclear definitions and inconsistent use of key terms can hinder the evaluation and interpretation of scientific evidence, and may pose significant obstacles to medical product development programs,” the group adds.
The FDA’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, published November 24, doesn’t stray far from the draft issued in December 2019, which divides the qualification process into three stages. 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 the basic information about the tool.
The ensuing FDA reviews usually take about three months. If asked by the FDA, the applicant submits a full qualification package that includes detailed descriptions of all studies, analyses, and results requested by the agency. The final review stage takes 10 months.
Edited by Michael Causey