Under the 21st Century Cures Act,1 enacted on December 13, 2016, a new section 507, Qualification of Drug2 Development Tools (DDT)3, was added to the Federal Food, Drug, and Cosmetic Act. Section 507 includes transparency provisions that apply to requestors’ submissions and FDA’s formal written determinations in response to such submissions4.
Consistent with the transparency provisions of section 507, FDA intends to publicly post the information contained in the table below. Please note that the transparency provisions of section 507 apply to Letters of Intents (LOIs), Qualification Plans (QPs), and Full Qualification Packages (FQPs) sent to FDA after December 13, 2016 (when the 21st Century Cures Act was enacted). In addition to these, FDA intends to publicly post any updates to an LOI, QP, or FQP and/or any other submission(s) that significantly impacts the DDT’s development.
The table below describes what will be publicly posted for an LOI, QP, FQP, and qualification decision, consistent with the transparency provisions of section 507. To view program specific submissions, please visit:
1 Further information regarding the 21st Century Cures Act can be found at https://www.congress.gov/114/bills/hr34/BILLS-114hr34enr.pdf. The content section pertinent to this letter is Subtitle B – Advancing New Drug Therapies, Sec. 3011 Qualification of drug development tools, which is largely codified at section 507 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), or 21 U.S.C. 357.
2 The term drug refers to both human drugs and biological products unless otherwise specified.
3 Section 507 of the FD&C Act defines “drug development tool” to include biomarkers and clinical outcome assessments, and “any other method, material, or measure that the Secretary determines aids drug development and regulatory review for purposes of this section.”
4 FD&C Act Sec. 507(c) (21 U.S.C. § 357(c)).
5 A biomarker can be a single concept or a panel of multiple concepts.