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:

DDT Submission Documents and/or Information FDA will 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 (i.e. Animal Model, Biomarker, Clinical Outcome Assessment)
  • DDT Name/Description
  • Proposed Context of Use
  • DDT Requestor's Submitted LOI Summary
  • Drug development need the DDT is intended to address
  • Notation if FDA consulted external experts
  • FDA Formal Written Decision 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 (i.e. Animal Model, Biomarker, Clinical Outcome Assessment)
  • DDT Name/Description
  • Proposed Context of Use
  • DDT Requestor's Submitted QP Summary
  • Notation if FDA consulted external experts
  • FDA Formal Written Decision 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 (i.e. Animal Model, Biomarker, Clinical Outcome Assessment)
  • DDT Name
  • Final Context of Use
  • DDT Requestor’s Submitted FQP Summary
  • Notation if FDA consulted external experts
Other Documents  
Qualification Determination
  • Requestor Name
  • DDT Type (i.e. Biomarker, Clinical Outcome Assessment)
  • DDT Name
  • FDA Formal Written Qualification  Determination Letter
  • FDA Executive Summary including final Context of Use and DDT use considerations
  • Redacted discipline-specific reviews
  • 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 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.