A message from Christopher Leptak at the Food and Drug Administration, Office of New Drugs

Under the 21st Century Cures Act enacted on December 13, 2016, new section 507 (“Qualification of Drug Development Tools”) was added to the Federal Food, Drug, and Cosmetic Act (FD&C Act). Although CDER had previously implemented a biomarker qualification program (or “legacy” program), section 507 establishes an updated, multi-stage process for DDT qualification.

This process includes three submission milestones: the Letter of Intent (LOI), the Qualification Plan (QP), and the Full Qualification Package (FQP).Section 507 also includes transparency provisions that address both requestors’ submissions and FDA’s formal written determinations in response to such submissions.

Beginning on August 15th, the programmatic responsibilities for the BQP will transition from the Office of Translational Sciences (OTS) to the Office of New Drugs (OND) in CDER. We will continue to support this program as part of our mission to bring safe, effective, and high-quality medications to patients.

As we transition BQP to the section 507 process and into OND, we will work hard to make those transitions as smooth as possible.

For additional information and periodic updates, please visit the Biomarker Qualification website

For questions or future communication regarding BQP, please email: This e-mail address is being protected from spambots. You need JavaScript enabled to view it