The FDA is planning to transition to a new drug development tool qualification process — as required by the 21st Century Cures Act — for clearing the use of biomarkers, clinical outcomes assessments and other methods to aid regulatory review.
The tool qualification process includes three requirements from the sponsor: a letter of intent, a qualification plan and a final, full qualification package.
The letters of intent should include descriptions of the development tool, proposed contexts of use and any notation if the FDA consulted external experts. The qualification plan and package also have similar requirements.
The FDA plans to publish the submitted documents — as well as the agency’s formal written responses — starting with those sent to the FDA after December 2016, when the Cures Act’s transparency provisions took effect. The FDA is urging sponsors to contact their respective qualification program with any questions.