Drugs

Updated Process for Qualification of Drug Development Tools Under New FD&C Act Section 507

Under the 21st Century Cures Act1 enacted on December 13, 2016, the new section 507 Qualification of Drug Development Tools (DDTs)2 was added to the Federal Food, Drug, and Cosmetic Act and formally 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)3. Section 507 also 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 Table 1 below. Please note that the transparency provisions of section 507 (as outlined in Table 1) will apply only to submissions (LOIs, QP, and FQPs) sent to FDA after December 13, 2016 (when the 21st Century Cures Act was enacted).

The goal is to transition from the legacy qualification program process to the new section 507 DDT Qualification Process through a phased approach. We are developing a transition plan for existing projects and templates for the section 507 submission documents (LOI, QP, FQP).

Please contact your respective DDT qualification program with questions.

FDA will proactively post documents and information consistent with new section 507(c) related to the three DDT submission milestones and other documents:

DDT SubmissionDocuments and/or Information FDA will proactively post on its website, consistent with new section 507(c)
LOI

Date of receipt and status (under consideration, accepted, or declined)

Requestor Name

DDT Type (e.g. Biomarker, Clinical Outcome Assessment)

DDT Name/Description

Proposed Context of Use (COU)

DDT Developer’s Submitted LOI Summary

Drug development need the DDT is intended to address

Notation if FDA consulted external experts

FDA Formal Written Determination Letter (accepting or declining to accept the LOI)

Qualification Plan (QP)

Date of receipt and status (under consideration, accepted, or declined)

Requestor Name

DDT Type (e.g. Biomarker, Clinical Outcome Assessment)

DDT Name/Description

Proposed COU

DDT Developer’s Submitted QP Summary

Notation if FDA consulted external experts

FDA Formal Written Determination Letter (accepting or declining to accept the QP)

Full Qualification Package (FQP)

Date of receipt and status (under consideration, accepted, or declined)

Requestor Name

DDT Type (e.g. Biomarker, Clinical Outcome Assessment)

DDT Name

Final COU

DDT Developer’s Submitted FQP Summary

Notation if FDA consulted external experts

FDA Formal Written Determination Letter (accepting or declining to accept the FQP)

Other documents 
Qualification decision

Requestor Name

DDT Type (e.g. Biomarker, Clinical Outcome Assessment)

DDT Name

FDA Formal Written Qualification Decision Letter

FDA Executive Summary including final COU and DDT use considerations

FDA rescission or modification letter (if applicable)

1 Details regarding the 21st Century Cures Act can be found at: https://www.congress.gov/bill/114th-congress/house-bill/34/text, with a pdf of the statutory text 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 Section 507 of the FD&C Act defines “drug development tool” to include biomarkers and clinical outcome assessments.
3 FD&C Act Sec. 507(a) (21 U.S.C. § 357(a)).
4 FD&C Act Sec. 507(c) (21 U.S.C. § 357(c)).

Page Last Updated: 06/22/2017
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