Drugs

21st Century Cures Act: Qualification of Drug Development Tools

Under the 21st Century Cures Act,1 enacted on December 13, 2016, a new section 507, Qualification of Drug Development Tools (DDT)2, was added to the Federal Food, Drug, and Cosmetic Act. Building on the qualification program that FDA had voluntarily established and implemented for many years (“the legacy qualification program”), the 21st Century Cures Act formally established an updated, multi-step process for DDT qualification. Qualification of a DDT is for a specific context of use (COU), and the qualified DDT may be used for the COU by any person in drug or biologics development. The qualification process includes three submissions: 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 the table 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). FDA’s 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, as well as section 507 submission documents (LOI, QP, FQP).

To engage with your respective DDT qualification program, see below.

Biomarker Qualification Program
Email: CDER-BiomarkerQualificationProgram@fda.hhs.gov

Clinical Outcome Assessments Qualification Program
Email: COADDTQualification@fda.hhs.gov
TEL: 301-796-0900

Animal Models Qualification Program
Email: AnimalModelQualification@fda.hhs.gov
TEL: 301-796-2210 

Transparency Provisions
FDA intends to publicly post the categories of information below regarding submissions, as well as FDA’s decision to Accept or Not Accept a submission (including recommendations for further DDT development).

DDT SubmissionDocuments and/or Information FDA will proactively post on its website, consistent with new section 507(c)
Letter of Intent
(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 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 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.”
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: 07/27/2018
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