Drug Development Tools: FDA Drafts Guidance on Qualification Process

Regulatory NewsRegulatory News | 13 December 2019 |  By 

The US Food and Drug Administration (FDA) on Friday issued draft guidance explaining its qualification process for drug development tools (DDTs) in line with the 21st Century Cures Act.
The 20-page draft guidance comes just ahead of the deadline set in the Cures Act and fulfills some of FDA’s Prescription Drug User Fee Act (PDUFA VI) commitments to enhance its DDT qualification pathway for biomarkers.
Section 507 of the Federal Food, Drug, and Cosmetic Act, as amended by the Cures Act, defines DDTs as biomarkers, clinical outcome assessments and “any other method, material, or measure that the Secretary determines aids drug development and regulatory review.” FDA adds that it has determined that animal models evaluated under the Animal Model Qualification Program (AMQP) fit within the definition as well.
Once qualified, FDA says a DDT can be used within its context of use (COU) to support regulatory submissions, including investigational new drug applications (INDs), new drug applications (NDAs) and biologics license applications (BLAs) for any drug or biologic.
“Encouraging the identification and use of reliable DDTs can significantly advance the development of new, safe, and effective drugs. Qualified DDTs allow integration of innovative technology and approaches to conditions or diseases that may create opportunities in new areas of drug development as knowledge of disease and pathogenesis advances,” FDA writes.
FDA explains that while the DDT qualification process is voluntary, requestors seeking qualification “must follow the three-stage process described in the Cures Act,” which includes submitting a letter of intent (LOI), qualification plan (QP) and full qualification package (FQP).
FDA also explains that drugmakers may still use DDTs that have not been qualified, or are qualified for a different COU, when appropriate and after seeking agreement with the appropriate review division.
The guidance itself provides a detailed overview of the general concepts surrounding the DDT qualification program, a discussion of each of the three stages of the qualification process and explains how qualified DDTs may be modified or rescinded.
Additionally, the guidance provides some technical details for submitting documents to the agency for the purposes of DDT qualification, including where to submit electronic documents and data standards for those submissions.
FDA notes that the guidance is not meant to address evidentiary standards or performance criteria for DDT qualification, nor does it address the qualification of medical device development tools.
FDA also withdrew its previous draft guidance on the topic from 2014.


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