FDA Guidance for Industry and FDA Staff: Qualification Process for Drug Development Tools [DRAFT]

This draft guidance provides FDA’s current thinking regarding the qualification process for drug development tools (DDTs) for a specific use, as defined in the 21st Century Cures Act. Qualification is a voluntary process that permits use of a DDT for its context of use— the defined boundaries within which the available data justifies use of the DDT(s)—across multiple drug development programs.

DDTs are methods, materials, or measures that have the potential to facilitate drug development.  Examples of types of DDTs include:

  • a clinical outcome assessment used to evaluate clinical benefit;
  • an animal model used for efficacy testing of medical countermeasures under the regulations commonly referred to as the Animal Rule[1];
  • a biomarker used for clinical trial enrichment.

With this draft guidance, FDA intends for individuals and organizations interested in qualifying a DDT to better understand the regulatory qualification process. DDTs are intended to accelerate the integration of innovation, clinical knowledge, and scientific advances into drug development while offering stakeholders opportunities to better target and expedite individual drug development programs.

For more information, please refer to the draft guidance found here: www.fda.gov/regulatory-information/search-fda-guidance-documents/qualification-process-drug-development-tools-guidance-industry-and-fda-staff?utm_campaign=FDA%20issues%20draft%20guidance%20on%20qualification%20of%20drug%20development%20tools&utm_medium=email&utm_source=Eloqua


[1] See 21 CFR 314.600-650 for drugs and 21 CFR 601.90-95 for biological products

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