USA – FDA enhances DDT qualification pathway for biomarkers

The US Food and Drug Administration (FDA) on Friday issued draft guidance explaining its qualification process for drug development tools (DDTs) in line with the 21st Century Cures Act.

The 20-page draft guidance comes just ahead of the deadline set in the Cures Act and fulfills some of FDA’s Prescription Drug User Fee Act (PDUFA VI) commitments to enhance its DDT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…